Install this theme
Bipartisanship arrived in Washington on Thursday, not that many in the media will hail it. That’s because the sweet harmony involved a 270-146 House vote to repeal ObamaCare’s 2.3% excise tax on medical devices.
What does it mean when FDA “clears” or “approves” a medical device?



When FDA review is needed prior to marketing a medical device, FDA will either:



FOLLOW US ON TWITTER

  1. "clear" the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or
  2. "approve" the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.


Whether a 510(k) or a PMA application needs to be filed depends on the classification of the medical device.

To acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is “substantially equivalent” to a device that is already legally marketed for the same use.

To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.



-

FOR PHOTOS OF 12 COMMON DEADLY MISCONNECTIONS CLICK HERE

-

www.ISO-80369.com
www.QDSyringeSystems.com
www.QDSS.co
www.Twitter.com/QDSyringe
www.SafetySyringe.cc

Premarket Notification ~ 510k Review Fees

Overview

On October 26, 2002 the Medical Device User Fee and Modernization Act of 2002 signed into law. This law authorizes FDA to charge a fee for medical device Premarket Notification 510(k) reviews. This application fee applies to most 510(k)s including Traditional, Abbreviated, and Special 510(k)s, but not those exempted or waived as noted below.

Small businesses may qualify for a reduced fee. Payment must be received on or before the time the 510(k) submission is submitted. If the submitter has not paid all fees owed, FDA will consider the submission incomplete and will not accept it for filing.

Fees

The review fees for 510(k) submissions are below:

.

FY 2012 Device Review User Fees (U.S. Dollars)

  • Submission:               510(k)    513(g)
  • Standard Fee:            $4,049    $2,971
  • Small Business Fee:    $2,024    $1,485

(≤$100 million in gross receipts or sales)

.

The applicable fee corresponds with the date of receipt of the submission by FDA. Please note that FDA will consider the 510(k) submission incomplete and will not accept it for filing until the fee is paid in full. That is, the date of receipt is the date that the submission has been received AND the fee is paid in full.

FDA will adjust these fees each year to account for inflation, changes in workloads, and other factors. The small business fee is 50% of the standard fee. FDA will announce the new fees for the next fiscal year in a Federal Register notice by August 1 of each year.

Exemptions and Waivers

-

The following exemptions or waivers apply:

-

Fee Exemptions and Waivers (No Fee for These)

-

Category:
Exemption or Waiver

-
Third-party 510(k):
Exempt from any FDA fee; however, the third-party does charge a fee for its review.

-
Any application for a device intended solely for pediatric use:    
Exempt from user fee. Please note that changing the intended use from pediatric use to adult use requires the submission of a new 510(k). The new 510(k) is subject to the 510(k) review fee at the time of submission.

-
Any application from a State or Federal Government entity:    
Exempt from any fee unless the device is to be distributed commercially.

-

When to Pay

-

Payment must be received at or before the time the 510(k) submission is submitted. If the submitter has not paid all fees owed, FDA will consider the submission incomplete and will not accept it for filing.

-

How/Where to Send Payment

-

Submit the information and payment in the following order

-

  1. If you believe you qualify as a Small Business and would like to qualify for reduced fees, submit a Small Business Qualification Certification. If you qualify, you will receive a Small Business Decision number. You must provide your Small Business Decision number on the Medical Device User Fee Cover Sheet at the time of submission to be eligible for reduced fees. FDA will not accept reduced fees without a Small Business Decision number and will not refund the difference between the standard fee and the small business fee after the submission has been received.
  2. Complete the Medical Device User Fee Cover Sheet and send a completed copy with your payment.
  3. Submit your Premarket Notification 510(k) and include a copy of the Medical Device User Fee Cover Sheet with your submission.
  4. Complete the Medical Device User Fee Cover Sheet

-

You should complete the Medical Device User Fee Cover Sheet (Form FDA-3601). The Medical Device User Fee Cover Sheet and instructions are available online.

-

You will need to register to create a Medical Device User Fee Cover Sheet. Please note that the User Fee Cover Sheet website was enhanced on March 1, 2005. Even if you have registered in the User Fee Cover Sheet system previously to March 1, 2005, you will need to follow the instructions as a “New User.”

-

You will need one of the following pieces of information to complete the registration process.

-

  • Organization #: 123456789
  • Dun and Bradstreet Number (DUNS) # 123456789
  • Employer Identification Number (EIN) #123456789

-

Additionally, you will need to identify a Principal Point of Contact (PPOC) in your organization who will be responsible for validating users for security purposes.

-

After you have registered and have created a user name and password, you will receive a confirmation email. You may then access the cover sheet creation page. A unique user fee Payment Identification Number will be generated on your cover sheet upon completion. You will need three copies of your completed User Fee Cover Sheet: one copy for your payment, one copy for your 510(k) submission, and one copy for your records.
-
Frequently Asked Questions addresses common questions regarding the Medical Device User Fee Cover Sheet.

-

Submit Your Payment

-

Send a printed copy of your User Fee Cover Sheet with your payment. Be sure to include the Payment Identification Number (beginning with MD) and the FDA P.O. Box on your check, bank draft, or U.S. Postal Money Order. The review fee may be submitted by mail, courier, or wire transfer.

-

Send your payment to:

By Mail:
Food and Drug Administration
P.O. Box 956733
St. Louis, MO 63195-6733

By Courier: 

If the check is sent by a courier, the courier may deliver the checks to:
US Bank
Attn: Government Lockbox 956733
1005 Convention Plaza
St. Louis, MO 63101
(Note: This address is for courier delivery only. Contact the US Bank at (314) 418-4821 if you have any questions concerning courier delivery.)

By Wire Transfer:

"As of 1/31/10 US Bank will no longer accept Wire Transfers"
Wire transfers are now processed through the Federal Reserve Bank of New York. You will need the following information to remit a payment:

FDA Deposit Account Number: 75060099
US Department of Treasury Routing/Transit Number or ABA: 021030004

Address:
Federal Reserve Bank of New York
TREAS NYC
33 Liberty Street
New York, NY 10045
Tel (212) 720-5000

Also include your User Fee Payment Identification Number from your Medical Device User Fee Cover sheet when you send payment by wire transfer.

Note: Your bank or financial institution may assess a fee for sending a wire transfer.

If needed for accounting purposes, FDA’s tax identification number is 53-0196965.

Fees should arrive at the bank at least 1 day before the application arrives at FDA. FDA recommends that you send the payment to the bank 4-5 business days before the application arrives at FDA so there is no delay in starting the review of your application. FDA records as the submission receipt date the latter of the following:

1. The date the submission was received by FDA; or
2. The date Bank notifies FDA that payment has been received.
Bank is required to notify FDA within 1-working day, using the Payment Identification Number.

Qualification for Small Business Fees

In FY2012 (October 1, 2011 through September 30, 2012), firms with annual gross sales and revenues with $100 million or less, including gross sales and revenues of all affiliates, partners, and parent firms, may qualify for lower rates for Premarket Notification 510(k) submissions.

An affiliate is defined by §737(8) of the FD&C Act: An affiliate means a business entity that has a relationship with a second business entity if, directly or indirectly,

  1. one business entity controls, or has the power to control, the other business entity; or
  2. a third party controls, or has power to control, both of the business entities.

To qualify, you must submit the MDUFMA Small Business Qualification Certification (Form FDA 3602). In addition, certified copies of your firm’s Federal Income Tax Return for the most recent taxable year, including certified copies of the income tax returns of all affiliates, partners, and parent firms must be provided.

The following guidance and form should be used.

FY2012 MDUFMA Small Business Qualification Worksheet and Certification


The Certification should be sent to:

MDUFMA Small Business Qualification
Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
10903 New Hampshire Avenue, WO66-4613
Silver Spring, MD 20993


FDA will review the Certification within 60 days and send its decision that the firm is, or is not, a small business eligible for reduced or waived fees. If your firm qualifies as a small business, the decision letter will include a Small Business Decision number. The Small Business Decision number is used on the Medical Device User Fee Cover Sheet (Form FDA 3601) to demonstrate that your firm is entitled to a reduced fee. If you submit a reduced fee to FDA without a Small Business Decision number, the submission will not be accepted for filing.

The small business status expires at the end of each fiscal year (September 30th). A new MDUFMA Small Business Qualification Certification must be submitted each year to qualify as a small business.

Questions concerning Small Business Qualification should be directed to Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at 301-796-7100 (800-638-2041).

_____________________

 (Source: www.FDA.gov)
_____________________

www.QDSyringeSystems.com
www.QDSS.co
www.Twitter.com/QDSyringe
www.SafetySyringe.cc

How Human Factors Lead to Medical Device Adverse Events

A Look At Human Factors

By Suzanne Rich, RN, CT, MA          FOLLOW US ON TWITTER
ADVERSE EVENTS involving medical devices or equipment can lead to serious problems, including incorrect or delayed diagnosis and treatment or patient injuries. When errors involving medical devices recur repeatedly, people typically blame the users instead of the real culprit, which is often a poorly designed interface between the medical device and the user. Human factors is the science that focuses on understanding and supporting how people interact with technology.
In health care, the objective of human factors is to improve human performance with medical products, including medical devices, and to reduce the likelihood of error or injury, thus improving patient and workplace safety.1 In this article, I’ll discuss some common problems and steps you can take to prevent them.
.

Design considerations

The complexity and diversity of medical devices used simultaneously contribute to human factors errors. A key objective of human factors in medical device design is to enhance the likelihood of good performance under less-than-ideal conditions. To minimize human factors problems, devices should be designed according to users’ needs, abilities, limitations, and work environments. This includes the design of the device’s user interface, which includes controls, displays, software, labels, and instructions—anything the user may need to operate and maintain a device.
.
Good design should include:
  • operation that’s intuitive and doesn’t require frequent reference to an instruction manual
  • easy-to-read displays
  • easy-to-use controls
  • appropriate connections of device-to-device and device-to-outlet for safe use
  • effective alarms
  • easy repair and maintenance.2
.
Consider three major areas when evaluating medical-device-related adverse events from a human factors perspective:
  1. user characteristics, including the person’s abilities and training and her expectations of the device
  2. device design considerations, which focus on the device-user interface, including
    instructions for use
  3. the environment in which the device
    is used, including the lighting, noise,
    distractions, and time constraints.1 , 2 
Let’s examine these elements in more detail, starting with the device user. For examples of errors in each major area, see Troubling human factors problems.
.

Training and expectations

.

Make sure everyone using a device has received training on it. Then consider a less obvious factor, the user’s expectations of how the device works. Whether a user is a health care professional or a patient, she may expect a device to work like another device that looks similar. For example, based on her experience, she may expect a device to deliver the same prescribed treatment or dose as a similar device, or expect the alarms to be in a specific sequence or pattern of sounds. Many reported I.V. fluid pump programming errors resulted when the actual device function wasn’t what the user expected.3
.

Looking at design

.

A user’s ability to interpret or understand device communication is often impaired by incomplete, confusing, or misleading labeling and instructions for use. Ambiguity about the sequence of steps required for device setup and operation can also be a factor.
Sometimes the instructions for use aren’t easily accessible, which prompts users to operate devices based on previous experience instead of on the requirements found in the labeling. An example of this problem is when the text or numeric font is difficult to find in the device’s display panel.
When similar devices are made by different manufacturers, the vocabulary in text displays may be inconsistent. For example, adverse events have involved devices that used different units of measure, such as cubic centimeters instead of milliliters. When devices display unfamiliar text abbreviations or words, this may further compound difficult or confusing navigation through menus to set up the device, leading to errors.
Make sure that when your facility chooses devices, it takes into account the following visual, auditory, and tactile features of the interface between user and device.
.

Visual considerations:

.

  • The user can see the device displays, labels, or markings.
  • Display screens are easy to see, have clear contrast, and are bright enough to be seen without glare.
  • The font is large enough to be read by all users.
.

Auditory considerations:

.

  • The user can easily hear and interpret alarms.
  • The sequence of sounds is appropriate in volume, frequency, tone, and pitch.
  • The alarm’s timing clearly defines the acuity of the warning and gives the user enough time to make adjustments and corrections.
.

Tactile considerations:

.

  • The device’s components can be connected easily.
  • The device’s components can’t be easily disconnected or connected by mistake. (Problems have been reported with some electrodes, cables, and I.V. tubing.)
  • The device’s components can be connected so that the user feels a “click” to help ensure a proper connection.
  • The user can feel the controls of knobs, buttons, switches, and keypads.
Instructions for maintaining and cleaning the device should be clear and include what compounds can and can’t be used. Some devices, such as electronic medical devices, shouldn’t be cleaned with fluids, which can leak into the device housing and cause performance problems and even fires. Some cleaning agents may degrade or otherwise affect a device’s plastic casings, impairing performance.
.

Consider the environment

.

Both user and device performance can be influenced by physical characteristics of the environment, such as adequate lighting, clear and unobstructed views of devices (especially those used for monitoring), and controls for temperature and humidity.
These workplace constraints can contribute to medical device errors or
adverse events:
  • staff with heavy workloads, such as multiple high-acuity patients
  • staff working double shifts
  • float and temporary staff who may be unfamiliar with the unit’s equipment
  • different brands or models of the same type of equipment within the same facility.
Some organizations have moved to using a single brand or model throughout their facilities.
.

Reporting problems

.

If an error or an adverse event occurs despite your best efforts, take action. Medical-device-related adverse events involving death or serious injury must be reported. Reporting near misses or events that could cause patient harm can help identify system improvements that can prevent similar adverse events in the future. Follow your facility’s policies and procedures. You can report events to MedWatch.  See the nearby link to MedWatch.
Addressing human factors in both the design and clinical use of medical devices mitigates risk, improves patient safety, and improves workplace safety.

.

 TROUBLING HUMAN FACTORS PROBLEMS

.

Adverse events reported to the Food and Drug Administration involving human factors errors range from the simple to the complex. Here are examples of errors in each major area involving human factors:4
User expectations. One error involved an otoscope and transilluminator that look similar but have different light intensities. During an urgent intervention, the health care provider picked up an otoscope, thinking it was a transilluminator. When he tried to use it to locate a child’s vein for an I.V. catheter insertion, the patient experienced a second-degree burn.
Device design. Another error concerned noninvasive blood pressure (BP) tubing that was mistakenly connected to I.V. tubing. The patient, who was being monitored in the ED with a noninvasive automatic BP device, also had an I.V. catheter. The BP cuff tubing was disconnected when the patient went to the bathroom, and it was reconnected upon his return. The patient’s wife found the patient “blue from the neck up.” Despite resuscitation efforts, he died. The BP cuff tubing had been connected to the I.V. catheter and had delivered about 15 mL of air. An autopsy confirmed a fatal air embolus.5
Environment. A safety issue was reported when newly purchased ventilators were placed into service in a trauma ICU. Staff immediately noted that the ventilators had an alarm that wasn’t audible when the patient-room door was closed. Although the devices weren’t defective, they weren’t suited to the environment where they were being used.


REFERENCES

1. FDA’s Human Factors Program: Promoting safety in medical device use. http://www.fda.gov/cdrh/humanfactors/index.html. Accessed March
27, 2008.
2. Sawyer D. Do it by design: An introduction to human factors. http://www.fda.gov/cdrh/humfac/doit.html. Accessed March 27, 2008.
3. Rich S. Medical devices and patient safety: The role of human factors. Association for Vascular Access Pre-Conference, Indianapolis, Ind., September 8, 2006.
4. Food and Drug Administration. Manufacturer and User Facility Device Experience (MAUDE). http://www.fda.gov/cdrh/maude.html. Accessed March 27, 2008.
5. Eakle M, et al. Luer-lock misconnects can be deadly. Nursing2005. 35(9):73, September 2005.

Suzanne Rich is a senior project manager of the patient safety staff at the Office of Surveillance and Biometrics, Center for Devices and Radiological Health at the Food and Drug Administration in Rockville, Md. (Article reprinted from June Nursing2008, Volume 38, Number 6, Pages 62-63)

—————————————-
 Source ~ www.FDA.org
—————————————-
FOR PHOTOS OF 12 COMMON DEADLY MISCONNECTIONS CLICK HERE 

—————————————-
www.ISO-80369.com
www.QDSyringeSystems.com
www.QDSS.co
www.Twitter.com/QDSyringe
www.SafetySyringe.cc
WARNING: DEADLY Luer connections

WARNING ~ DEADLY Luer connections

FOLLOW US ON TWITTER

Hospitals and other healthcare facilities depend on a variety of catheters, tubing and syringes to deliver medications and other substances to patients through vascular, enteral, respiratory, epidural and intrathecal delivery systems.




These delivery systems frequently employ fittings called Luer connectors to link various system components. The male and female components of Luer connectors join together to create secure yet detachable leak-proof connections. Multiple connections between medical devices and tubing are common in patient care.



Unfortunately, because Luer connectors are ubiquitous, easy-to-use and compatible between different delivery systems, clinicians can inadvertently connect wrong systems together, causing medication or other fluids to be delivered through the wrong route. Such errors have occurred in diverse clinical settings, causing serious patient injuries and deaths. The Food and Drug Administration (FDA), The Joint Commission (TJC), the Institute for Safe Medication Practices (ISMP), the United States Pharmacopeia (USP), the ECRI Institute and others have all received reports of misconnection errors. The problem is well-known and well documented. Yet despite efforts on the part of FDA and other organizations to reduce misconnections through education, protocol and monitoring, the use of Luer connectors in incompatible medical delivery systems continues to create situations where dangerous misconnections can, and do, occur.



To further reduce the occurrence of these misconnections, FDA is actively participating in an international effort to develop and implement standards for noninterchangeable connectors for small bore medical connectors. A joint working group established by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) leads this effort to develop a series of standards for incompatible connectors used in intravascular (IV), breathing systems, enteral, urethral/urinary, cuff inflation and neuraxial applications. Once implemented, these connectors will facilitate correct connections and eliminate incompatible tubing misconnections.


Until standards are completed and manufacturers design and produce products that can’t be misconnected, all interested parties must continue their efforts to keep these dangerous misconnections from happening. “Actions must be taken at the patient bedside, within all levels of health care organizations and throughout the channels of regulation, manufacturing and distribution of these devices in order to eradicate the serious problem of tubing misconnections,” said Peter B. Angood, M.D., Vice President and Chief Patient Safety Officer for The Joint Commission (TJC).


These Medical Device Safety photos are one of those efforts. These photos provided a graphic depiction of misconnection cases that have occurred, coupled with recommendations from TJC on ways to prevent these types of errors.

We hope you’ll post these Medical Device Safety photos as a reminder to staff that these errors can occur in any clinical setting. We also urge you to use the case synopses and recommendations as ongoing training materials. To that end, we have made the photos, case studies and additional resources available, free of charge, at www.fda.gov/cdrh/luer. We encourage you to visit this web site to download and make further use of these materials. Let’s continue to work together to prevent these tragic errors.


Daniel G. Schultz, M.D.
Director, Center for Devices and Radiological Health
U.S. Food and Drug Administration
~
 Source ~ www.FDA.org
~
FOR PHOTOS OF 12 COMMON DEADLY MISCONNECTIONS CLICK HERE 

~

www.ISO-80369.com
www.QDSyringeSystems.com
www.QDSS.co
www.Twitter.com/QDSyringe
www.SafetySyringe.cc
510k Frequently Asked Questions

510k  Q & A

Distributors
I would like to distribute a manufacturer’s product under my own company name. Do I need to submit a 510(k)?

FOLLOW US ON TWITTER

No, the manufacture should submit the 510(k), if required for the device. As required under 21 CFR 801.1(c), where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, “Manufactured for ABC Company,” “Distributed by ABC Company,” or any other wording that expresses the facts.  The distributor should forward all product complaints to the manufacturer for evaluation in accordance with 21 CFR 820.198 Complaint files.

Foreign Manufacturers

 

Can foreign companies submit a Premarket Notification 510(k)?

Yes. The foreign manufacturer may submit a 510(k) directly to FDA. For convenience, a foreign manufacturer may receive assistance from a U.S. entity and may use a contact person residing in the U.S.

Registration

 

Do I need to register my facility before I submit a 510(k)?

No. If you are a new company and do not manufacture any medical devices, you should not register until you are within 30 days of manufacturing and distributing the device. The 510(k) submission should state that you are not currently registered. Information on how to register your facility is available at Registering Your Establishment.

Quality System

 

Do I need to provide documentation that my facility complies with the Quality System in my 510(k)?

No. However, if you are submitting a Special 510(k), you must provide declaration of conformity with the design controls aspect of the Quality System.

Do I need to have my facility inspected to the Quality System regulations before I submit a 510(k)?

No. There is no pre-approval inspection as a prerequisite to 510(k) clearance. However, you should be prepared for an FDA inspection at any time.


____________________

 Source ~ www.FDA.org

____________________

 
www.QDSyringeSystems.com
www.QDSS.co
www.Twitter.com/QDSyringe
www.SafetySyringe.cc
510k ~ Alternate Approaches to Demonstrating Substantial Equivalence

The New 510(k) Paradigm Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications

Introduction                                                         

FOLLOW US ON TWITTER

This document provides guidance to the regulated industry and reviewers on two alternative approaches that may be used, under appropriate circumstances, to demonstrate substantial equivalence. It establishes procedures regarding the use of consensus standards in the premarket review process (section 514 of the Act, as amended by section 204 of the FDAMA) and reflects other changes to the 510(k) Program that have resulted from enactment of the new law, such as increased reliance on postmarket controls to expedite premarket review (section 513 of the Act, as amended by section 205 of the FDAMA). In addition, it incorporates concepts that have arisen out of the Center’s organizational transformation initiative, including a new emphasis on the use of guidance documents and special controls. The alternative approaches described in this guidance document should streamline the 510(k) preparation and review processes, thus conserving industry and Agency resources while still protecting the public health.
 -

Background

-

Under section 510(k) of the Act, a person who intends to introduce a device into commercial distribution is required to submit a premarket notification, or 510(k), to FDA at least 90 days before commercial distribution is to begin. Section 513(i) of the Act states that FDA may issue an order of substantial equivalence only upon making a determination that the device to be introduced into commercial distribution is as safe and effective as a legally marketed device. Under 21 CFR 807.87, FDA established the content requirements for premarket notifications to be submitted by device manufacturers in support of the substantial equivalence decision. FDA has, however, discretion in the type of information it deems necessary to meet those content requirements. For example, to allocate review resources more effectively to the highest risk devices, FDA developed a tiering system based on the complexity and the level of risk posed by medical devices. Under this system, the substantial equivalence determination for low risk devices is based primarily on descriptive information and a labeling review, while the decision for higher risk devices relies on performance data.

-

In a further effort to manage FDA’s workload and allocate resources most appropriately, the Agency exempted Class I devices for which it determined that premarket notification requirements were not necessary to provide reasonable assurance of safety and effectiveness.

-

Between the passage of the Medical Device Amendments of 1976 and the FDAMA, FDA exempted 574 generic types of Class I devices from the requirement of premarket notification. As a result of the FDAMA, all Class I devices are exempt from the requirement of premarket notification, unless the device is intended for a use that is of substantial importance in preventing impairment to human health or presents a potential unreasonable risk of illness or injury (“reserved” criteria). Therefore, only those Class I devices that meet the reserved criteria remain subject to the premarket notification requirement. (See 63 FR 5387, February 2, 1998, for a listing of Class I “reserved” devices.)

-

The FDAMA also gave FDA the authority to directly exempt certain Class II devices rather than first down-classifying them to Class I before they become eligible for exemption. On January 21, 1998, FDA published a listing of Class II devices that no longer require premarket notification. (See 63 FR 3142.) In the future, additional Class II devices may become exempt from the premarket notification requirement as FDA considers additional devices for exemption.

-

The last phase of the Agency’s effort to evaluate which devices should be subject to 510(k) review involves the preamendments Class III devices. Preamendments Class III devices for which general controls or special controls are sufficient to ensure safety and effectiveness will eventually be down-classified to either Class I (510(k) exempt or reserved) or to Class II, respectively. Those preamendments Class III devices that are not appropriate for reclassification will remain in that class and be subject to either premarket approval (PMA) or product development protocol (PDP) requirements. It is anticipated that, as a result of this reclassification effort, the premarket notification process will be primarily reserved for Class II devices and a few “reserved” Class I devices. Until a preamendments Class III device type becomes subject to a regulation requiring premarket approval, however, the device type will remain subject to the premarket notification requirement.

-

The New 510(k) Paradigm

-

To streamline the evaluation of premarket notifications for the reserved Class I devices, Class II devices subject to premarket notification, and preamendments Class III devices for which FDA has not yet called for PMAs, the Agency has developed “The New 510(k) Paradigm.” Attachment 1 outlines the New Paradigm, which presents device manufacturers with two new optional approaches for obtaining marketing clearance for devices subject to 510(k) requirements. While the New Paradigm maintains the traditional method of demonstrating substantial equivalence under section 510(k) of the Act, it also presents the “Special 510(k): Device Modification” option, which utilizes certain aspects of the Quality System Regulation, and the “Abbreviated 510(k)” option, which relies on the use of guidance documents, special controls, and recognized standards to facilitate 510(k) review. Use of either alternative, however, does not affect FDA’s ability to obtain any information authorized by the statute or regulations.

-

A. Special 510(k): Device Modification

-

The Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629) amended section 520(f) of the Act, providing FDA with the authority to issue regulations requiring pre-production design controls. Specifically, section 520(f)(1)(A) states that FDA may prescribe regulations to require “… that the methods used in, and the facilities and controls used for, the manufacture, pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device), packing, storage, and installation of a device conform to current good manufacturing practice, as prescribed in such regulations, to assure that the device will be safe and effective and otherwise in compliance with this Act.” This change in the law was based on findings that a significant proportion of device recalls were attributed to faulty design. Under the authority provided by the SMDA, FDA revised its current good manufacturing practice requirements to include pre-production design controls that device manufacturers must follow when initially designing devices or when making subsequent modifications to those designs. (See 21 CFR 820.30 Subpart C - Design Controls of the Quality System Regulation.)

-

Effective June 1, 1997, manufacturers of Class II, Class III, and certain Class I devices are required to follow design control procedures when originally developing devices and for subsequent modifications. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under 21 CFR 820.30. In accordance with the Quality System Regulation, manufacturers must have a systematic set of requirements and activities for the management of design and development, including documentation of design inputs, risk analysis, design output, test procedures, verification and validation procedures, and documentation of formal design reviews. In this process, the manufacturer must ensure that design input requirements are appropriate so the device will meet its intended use and the needs of the user population. The manufacturer must also establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Thus, manufacturers may need to refine their device design requirements as verification and validation results are obtained. The design specifications that result from this process are the design outputs, which form the basis for the device master record (DMR). (See 21 CFR 820.3(i).) The DMR is subject to inspection by FDA personnel.

-

Since design control requirements are now in effect and require the manufacturer to conduct verification and validation studies of a type that have traditionally been included in 510(k) submissions, the Agency believes that it may be appropriate to forgo a detailed review of the underlying data normally required in 510(k)s. For this reason, FDA is allowing an alternative to the traditional method of demonstrating substantial equivalence for certain device modifications. For these well-defined modifications, the Agency believes that the rigorous design control procedure requirements produce highly reliable results that can form, in addition to the other 510(k) content requirements specified in Attachment 2, a basis for the substantial equivalence determination. Under the Quality Systems Regulation, data that is generated as a result of the design control procedures must be maintained by the manufacturer and be available for FDA inspection.

-

Under the New 510(k) Paradigm, a manufacturer should refer to 21 CFR 807.81(a)(3) and the FDA guidance document entitled, “Deciding When to Submit a 510(k) for a Change to an Existing Device” to decide if a device modification may be implemented without submission of a new 510(k). If a new 510(k) is needed for the modification and if the modification does not affect the intended use of the device or alter the fundamental scientific technology of the device, then summary information that results from the design control process can serve as the basis for clearing the application.1

-

Under this option of the Paradigm, a manufacturer who is intending to modify his/her own legally marketed device2 will conduct the risk analysis and the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements. Once the manufacturer has ensured the satisfactory completion of this process, a “Special 510(k): Device Modification” may be submitted. While the basic content requirements of the 510(k) (21 CFR 807.87) will remain the same, this type of submission should also reference the cleared 510(k) number3 and contain a “Declaration of Conformity” with design control requirements. Refer to Attachment 2 for the contents of a “Special 510(k): Device Modification” with a “Declaration of Conformity” to design controls.

-

___________________

-

1The terms “intended use” and “fundamental scientific technology” are used in the same manner as when used to define the limitations of exemptions from section 510(k) of the Act as found in each of the product classification regulations, 21 CFR 862-892, e.g., 21 CFR §§862.9, 864.9, and 866.9.

-

2Although not subject to the design control procedure requirements of the Quality System Regulation, manufacturers of reserved Class I devices may elect to comply with this provision of the regulation and submit Special 510(k)s.

-

3Manufacturers of preamendments devices may submit Special 510(k)s. See footnote 6 of Attachment 2 for information that should be included in a Special 510(k) under this circumstance.

-

________________

-

Under the Quality System Regulation, manufacturers are responsible for performing internal audits to assess their conformance with design controls. A manufacturer could, however, use a third party4 to provide a supporting assessment of the conformance. In this case, the third party will perform a conformance assessment for the device manufacturer and provide the manufacturer with a statement to this effect. The marketing application should then include a declaration of conformity signed by the manufacturer, while the statement from the third party should be maintained in the DMR. As always, responsibility for conformance with design control requirements rests with the manufacturer.

-

In order to provide an incentive for manufacturers to choose this option for obtaining Agency clearance for device modifications, the Office of Device Evaluation (ODE) intends to process Special 510(k)s within 30 days of receipt by the Document Mail Center (DMC). The Special 510(k) option will allow the Agency to review modifications that do not affect the device’s intended use or alter the device’s fundamental scientific technology within this abbreviated time frame. The Agency does not believe that modifications that affect the intended use or alter the fundamental scientific technology of the device are appropriate for review under this type of application, but rather should continue to be subject to the traditional 510(k) procedures (i.e., “Traditional 510(k)”) or may be subject to an Abbreviated 510(k) as described below.

-

FDA believes that to ensure the success of the Special 510(k) option of the Paradigm, there must be a common understanding of the types of device modifications that may gain marketing clearance by this path. In this vein, it is critical that industry and Agency staff can easily determine whether a modification is appropriate for submission as a Special 510(k). To optimize the chance that a Special 510(k) will be accepted and promptly cleared, 510(k) submitters should evaluate each modification against the considerations described below to insure that the particular change does not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

-

I. Intended Use

-

As discussed earlier, modifications to the indications for use of the device or any labeling change that affects the intended use of the device should not be submitted as a Special 510(k). Therefore, FDA recommends that submitters of Special 510(k)s highlight, or otherwise prominently identify, all changes in the proposed labeling that may result from modifications to their legally marketed device. In addition, it should be clearly stated in the Special 510(k) that the intended use of the modified device, as described in its labeling, has not changed as a result of the modification(s).

-

_______________

-

4 This use of a third party should not be confused with the Agency’s Third Party Review Program where recognized third parties review entire 510(k) submissions.

-

_____________________________

-


II. Fundamental Scientific Technology

-

Special 510(k)s should also not be submitted for modifications that have the potential to alter the fundamental scientific technology of the device. These types of changes generally include modifications to the device’s operating principle(s) or mechanism of action, such as automation of a manual device or incorporation of a sensing or feedback circuit. Specific examples that illustrate these types of changes that alter the fundamental scientific technology and thus should not be submitted as Special 510(k)s include:

-

  1. A change in a surgical instrument that uses a sharpened metal blade to one that cuts with at a laser;
  2. A change in an in vitro diagnostic (IVD) device that uses immunoassay technology to one that uses nucleic acid hybridization or amplification technology;
  3. Incorporation of a sensing mechanism in a device to allow the device to function “on demand” rather than continuously.

-

In addition, the Agency is concerned with changes in materials in certain devices. While FDA acknowledges that many such changes can be processed as Special 510(k)s, there are certain types of changes in materials that may raise safety or effectiveness issues that continue to warrant a more intensive evaluation by the Agency. This includes a change in material(s) in an implant, or other device that contacts body tissues or fluids, to a material type that has not been used in other legally marketed devices within the same classification regulation for the same intended use (i.e., “legally marketed predicate device”). For example, a change in a material in a finger joint prosthesis from a known metal alloy to a ceramic that has not been used in a legally marketed predicate, should not be submitted as a Special 510(k). Similarly, a change in a device’s active ingredient or agent to one that has not been used in other legally marketed predicate devices should not be submitted for review as a Special 510(k). For example, if a manufacturer of a contact lens disinfecting solution wanted to change from hydrogen peroxide to an antiseptic that had not been previously used in a legally marketed predicate, such a change would not be appropriate for review as a Special 510(k). Both of the above types of modifications involve major changes in the principle component of the device and thus would be considered a change to the fundamental scientific technology of the device and should be submitted for review as either Abbreviated or Traditional 510(k)s.

-

A change, however, in formulation in a material or a change to a type of material that has been used in other legally marketed devices within the same classification regulation for the same intended use could be reviewed as a Special 510(k). This should be true for both non-contacting devices as well as implants and devices that contact body tissues or fluids. Thus, a manufacturer of a hip implant could change from one alloy to one that has been used in another legally marketed predicate through the submission of a Special 510(k). Similarly, a contact lens manufacturer could submit a Special 510(k) for a change in their polymer to another material that has been used in a legally marketed predicate. Finally, changes in an inactive or secondary ingredient/agent should be appropriate for review as Special 510(k)s as this should not be considered a major change to the fundamental scientific technology of the device. For example, a manufacturer of a urologic catheter could submit a Special 510(k) to add an antimicrobial coating to the device if the coating has been used on another legally marketed predicate of the same material.

-

Device modifications that should be appropriate for review as Special 510(k)s also include those changes identified below:

-

a. Energy type
b. Environmental specifications
c. Performance specifications
d. Ergonomics of the patient-user interface
e. Dimensional specifications
f. Software or firmware
g. Packaging or expiration dating
h. Sterilization

-

It should be noted that in cases where FDA has issued guidance, established special controls, or recognized standards that address issues such as device testing or performance, manufacturers should consider this in their implementation of design control requirements. For example, if a manufacturer is modifying a contact lens, then the manufacturer’s design control inputs should include the special controls that FDA has established for this device. Further, if a manufacturer modifies an in vitro diagnostic, the manufacturer’s design inputs should include any recognized clinical standards such as those developed by the National Committee of Clinical Laboratory Standards (NCCLS) or a reasonable alternative. Thus, submitters of Special 510(k)s need to be aware of any relevant guidance documents, special controls, or recognized standards that apply to their device and that should be addressed by their design control processes.

-

III. Clinical Considerations

-

FDA recognizes that clinical evaluation may be involved in the validation of the design of a modified device. Manufacturers are reminded that all clinical investigations must conform to the applicable regulations, including 21 CFR Parts 812, 50 and 56. Therefore, collection of clinical data to support a Special 510(k) may require submission of an investigational device exemptions (IDE) application to FDA. The fact that a significant risk device investigation was conducted to support any of the activities listed above, however, does not necessarily preclude the submission of a Special 510(k).

-

Manufacturers who intend to conduct clinical investigations of a modified device as part of design validation are encouraged to contact the appropriate ODE review division before preparing a Special 510(k). When a clinical investigation is necessary to answer safety and effectiveness questions relating to a particular modification, the Agency believes that the modification is likely to have gone beyond that which is suitable for review as a Special 510(k). In contrast, where design validation involves clinical evaluation intended to ensure that the modified device meets user requirements as opposed to patient safety and effectiveness or to demonstrate continued conformance with a special control or recognized standard, FDA believes that the Special 510(k) may be the appropriate submission.

-

B. Abbreviated 510(k)

-

Over the past few years, FDA has been placing greater emphasis on the development of guidance documents to communicate regulatory and scientific expectations to industry. In the 510(k) area, numerous guidance documents exist, while others are under development for Class I, Class II and preamendments Class III devices. With the advent of Good Guidance Practices, device ­specific guidance documents are developed with public participation. The main focus of these guidance documents is the identification of the information recognized as appropriate for marketing authorization. FDA believes that use of these device-specific guidances may provide an effective means of streamlining the review of 510(k)s through a reliance on a “summary report” outlining adherence to relevant guidance documents. A 510(k) submission that conforms with an FDA guidance document should be easier to prepare and review, thus resulting in a more expeditious evaluation and clearance of the 510(k).

-

The SMDA introduced the concept of special controls as a means by which the safety and effectiveness of Class II devices can be assured. Special controls are defined in section 513(a)(1)(B) of the Act as those controls, such as performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations and other appropriate actions that provide reasonable assurance of the device’s safety and effectiveness. As in the case of guidance documents, summary information that describes how a special control(s) has been used to address a specific risk or issue should reduce the time and effort to prepare and review 510(k)s.

-

In addition to device-specific guidance documents (hereinafter referred to as guidance documents) and special controls, CDRH is committed to recognizing individual consensus standards. In fact, the FDAMA amended section 514 of the Act to specifically authorize the Agency to recognize all or part of national and international standards through publication of a notice in the Federal Register. Recognized standards could be cited in guidance documents or individual policy statements, or established as special controls that address specific risks associated with a type of device. IEC 60601-1 is an example of such a consensus standard. It has broad applicability to many electromedical devices. FDA’s recognition of this standard, combined with modified review procedures, should streamline the review of many 510(k)s for devices covered by the standard. Finally, by using accompanying particular standards to adapt a general standard to a specific device, the 510(k) review process may be further expedited.

-

Therefore, device manufacturers may choose to submit an Abbreviated 510(k) when: (1) a guidance documents exists, (2) a special control has been established, or (3) FDA has recognized a relevant consensus standard.5 An Abbreviated 510(k) submission must include the required elements identified in 21 CFR 807.87. In addition, manufacturers submitting an Abbreviated 510(k) that relies on a guidance document and/or special control(s) should include a summary report that describes how the guidance document and/or special control(s) were used during device development and testing. (See Attachment 3.) The summary report should include information regarding the manufacturer’s efforts to conform with the guidance document and/or special control(s) and should outline any deviations. Persons submitting an Abbreviated 510(k) that relies on a recognized standard should provide the information described in Attachment 3 (except for the summary report) and a declaration of conformity to the recognized standard. (See Attachment 4.) Such persons should also refer to the Agency’s guidance entitled, “Guidance on the Recognition and Use of Consensus Standards.”

-

In an Abbreviated 510(k), a manufacturer will also have the option of using a third party to assess conformance with the recognized standard. Under this scenario, the third party will perform a conformance assessment to the standard for the device manufacturer and should provide the manufacturer with a statement to this effect. Like a Special 510(k), the marketing application should include a declaration of conformity signed by the manufacturer, while the statement from the third party should be maintained in the DMR pursuant to the Quality System Regulation. Responsibility for conformance with the recognized standard, however, rests with the manufacturer, not the third party.

-

The incentive for manufacturers to elect to provide summary reports on the use of guidance documents and/or special controls or declarations of conformity to recognized standards will be an expedited review of their submissions. While abbreviated submissions will compete with traditional 510(k) submissions, it is anticipated that their review will be more efficient than that of traditional submissions, which tend to be data intensive. In addition, by allowing ODE reviewers to rely on a manufacturer’s summary report on the use of a guidance document and/or special controls and declarations of conformity with recognized standards, review resources can be directed at more complicated issues and thus should expedite the process.

-

_______________

-

5For a current list of FDA recognized standards, please refer to CDRH’s home page at http://www.fda.gov/cdrh or CDRH’s Facts on Demand at 1-800-899-0381.

-

_______________

-

Conclusion

-

FDA believes that the New 510(k) Paradigm will provide considerable flexibility for the medical device industry in demonstrating substantial equivalence in 510(k) submissions. The principles presented in this guidance document will be implemented through changes in the administrative processes and do not require changes to either the premarket notification regulation (21 CFR 807 Subpart E Premarket Notification Procedures) or to the Act. As experience is gained by the industry in preparing Special and Abbreviated 510(k)s and by FDA in evaluating these new types of 510(k) submissions, this guidance document may be updated and revised. CDRH will create and update a “New 510(k) Paradigm” website on the CDRH home page with information regarding this guidance as it becomes available. Device manufacturers should access this website for copies of Special/Abbreviated 510(k) coversheets, checklists, and additional information regarding implementation of the New Paradigm.

-

Effective Date: This guidance document is effective March 20, 1998.

-

____________________________________

Flow Chart of The New 510(k) Paradigm

_______________________________

Attachment 2

"Special 510(k): Device Modification"
Content

A Special 510(k): Device Modification should include:

  • A coversheet clearly identifying the application as a “Special 510(k): Device Modification”;
  • The name of the legally marketed (unmodified) device and the 510(k) number under which it was cleared6,7 ;
  • Items required under §807.87, including a description of the modified device and a comparison to the cleared device, the intended use of the device, and the proposed labeling for the device;
  • A concise summary of the design control activities. FDA may consider the information generated from these activities to be “appropriate supporting data” within the meaning of §807.87(g). This summary should include the following:

    • An identification of the Risk Analysis method(s) used to assess the impact of the modification on the device and its components as well as the results of the analysis;
    • Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and the acceptance criteria applied; and
    • A declaration of conformity with design controls. The declaration of conformity should include:

      1. A statement that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met; and
      2. A statement that the manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

        ** The above two statements should be signed by the designated individual(s) responsible for those particular activities.

  • - Indications for Use enclosure.
     

_____________________________________

-

6 When the legally marketed (unmodified) device is a preamendments device, the submitter should clearly state that the device is a preamendments device, is legally marketed, and has not been the subject of premarket notification clearance. (Refer to “Documentation Required for Preamendments Status” for the procedures for demonstrating preamendments status. Submitters should maintain this information in their files.)

-

7 In cases where the referenced 510(k) was submitted under a different name than that of the submitter of the Special 510(k), the Agency recommends that a statement to this effect be included in the Special 510(k) and that the submitter maintain adequate information demonstrating his legal right to distribute the device.

-

8 If a recent Quality System inspection has resulted in the issuance of a violative inspection report, the manufacturer should be prepared to describe those corrective actions taken, if needed, that form the basis for the declaration of conformity.

-

_________________________________________

 -

Attachment 3
"Abbreviated 510(k)"
Content
An Abbreviated 510(k) should include:

  • A coversheet clearly identifying the application as an “Abbreviated 510(k)”;
  • Items required under §807.87, including a description of the device, the intended use of the device, and the proposed labeling for the device;
  • For a submission that relies on a guidance document and/or special control(s), a summary report that describes how the guidance and/or special control(s) were used to address the risks associated with the particular device type. (If a manufacturer elects to use an alternative approach to address a particular risk, sufficient detail should be provided to justify that approach.);
  • For a submission that relies on a recognized standard, a declaration of conformity to the standard. (The declaration should be submitted in accordance with Attachment 4.);
  • Data/information to address issues not covered by guidance documents, special controls, and/or recognized standards; and
  • Indications for Use enclosure.

-

________________________________

-

Attachment 4
Declaration of Conformity to a Recognized Standard

In preparing a declaration of conformity to recognized standards, manufacturers should refer to the guidance document entitled, “Guidance on the Recognition and Use of Consensus Standards.” In accordance with this guidance, declarations of conformity to recognized standards should include the following:

  • An identification of the applicable recognized consensus standards that were met;
  • A specification, for each consensus standard, that all requirements were met, except for inapplicable requirements or deviations noted below;
  • An identification, for each consensus standard, of any way(s) in which the standard may have been adapted for application to the device under review, e.g., an identification of an alternative series of tests that were performed;
  • An identification, for each consensus standard, of any requirements that were not applicable to the device;
  • A specification of any deviations from each applicable standard that were applied (e.g., deviations from international standards which are necessary to meet U.S. infrastructure conventions such as the National Electrical Code (ANSI/NFPA 70));
  • A specification of the differences that may exist, if any, between the tested device and the device to be marketed and a justification of the test results in these areas of difference; and
  • The name and address of any test laboratory or certification body involved in determining the conformance of the device with the applicable consensus standards and a reference to any accreditations of those organizations.

———————-

www.QDSyringeSystems.com
www.QDSS.co
www.Twitter.com/QDSyringe
www.SafetySyringe.cc

Medical Device Fellowship Program

Medical Device Fellowship Program (EEP, OCD, CDRH)

Introduction 

FOLLOW US ON TWITTER

The CDRH Medical Device Fellowship Program (MDFP) provides opportunities for health professionals to participate in the FDA regulatory process for medical devices. MDFP is part of External Expertise and Partnerships (EEP) in the Office of the Center Director in CDRH. In addition to MDFP, other components of EEP include Technology Transfer and Partnerships, and the Critical Path Initiative.

-

CDRH regulates a wide array of medical devices and is involved with the latest medical device cutting-edge technology areas such as genomics, proteomics, diagnostics for personalized medicine, percutaneous heart valves, artificial hearts, tissue engineered wound dressing with cells, and bone void fillers with growth factors, and many others.

-

To keep pace with the rapid development of new technology, and to make decisions based on the best scientific information and knowledge available, CDRH routinely consults with experts in the academic community, other government entities, clinical practice, and the military. By filling gaps in expertise for a finite period of time, EEP enhances the efficiency and effectiveness of CDRH operations. EEP is the focal point of all CDRH fellowships and interorganizational partnerships. EEP also fosters scientific innovation by helping offices form partnerships with academia, private sector organizations, and government agencies.

-

CDRH established MDFP to increase the range and depth of collaborations between CDRH and the outside scientific community. The MDFP offers short and long-term fellowship opportunities for individuals interested in learning about the regulatory process and sharing their knowledge and experience with medical devices from the relatively simple to the highly complex.

-

Physicians with clinical or surgical expertise, engineers in biomedical, mechanical, electrical and software areas, and individuals from many other scientific disciplines have participated in the fellowship program. Opportunities are available for students in many areas as well.

-

Career Development

-

Learn about the FDA approval process for medical devices:

-

  • medical device design
  • clinical trial design and data
  • safety and efficacy evaluation
  • materials, performance, bioeffects and standards
  • adverse events

-

Public Service

-

  • Join CDRH’s mission to protect the public health by ensuring that medical devices are safe and effective
  • Share your expertise on complex device issues
  • Make a difference in the lives of patients and consumers
FDA and Device Approvals

New FDA guidance on considerations used in device approval, de novo decisions
Clinical data, risks, benefits and patient risk tolerance outlined in process

.

The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during pre-market review.

.

Premarket approval (PMA) is the FDA process of scientific and regulatory review used to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential unreasonable risk of illness or injury. The de novo process is available for low- and moderate-risk devices that have been found not substantially equivalent (NSE) to existing devices.

.

When evaluating PMA applications or de novo petitions, the FDA relies upon valid scientific evidence to assess safety and effectiveness. Both clinical and non-clinical data play a role in FDA’s benefit-risk determinations. 

.

The guidance includes a worksheet for device reviewers that incorporates the principal factors that influence benefit-risk determinations, such as the type, magnitude and duration of a risk or benefit, the probability that a patient will experience the risk, patient tolerance for risk, availability of alternative treatments, and the value the patient places on treatment. 

.

The guidance:

.

  • outlines the systematic approach FDA device reviewers take when making benefit-risk determinations during the premarket review process
  • provides manufacturers a helpful tool that explains the various principal factors considered by the agency during the review of PMA applications, the regulatory pathway for high-risk medical devices, and de novo petitions, a regulatory pathway available for novel, low- to moderate-risk devices
  • describes an approach that takes into account patients’ tolerance for risks and perspectives on benefits, as well as the novelty of the device.

.

“This guidance clarifies this process for industry, which will provide manufacturers with greater predictability, consistency and transparency in FDA decision-making while allowing manufacturers and the FDA to use a common framework for benefit-risk determinations,“ said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health (CDRH).

.

The FDA will also increase the transparency of the decision-making processes by describing the worksheet analysis in the Summary of Safety and Effectiveness Data for PMAs and the decision summary review memos for de novo decisions.

.

“In addition to bringing clarity to our decision making for industry, this guidance will provide our reviewers with uniform and consistent guidelines to assess probable benefits and risks,” said Shuren.

.

CDRH will train medical officers, review staff managers and device reviewers on the guidance to assure the guidance is applied consistently to submissions and petitions.  CDRH reviewers will begin applying the guidance to incoming PMA and de novo submissions and to submissions already under review with decisions beginning on May 1.

.

The FDA is also developing external training modules to help industry and device sponsors understand how CRDH will apply the guidance.

.

For more information:
Medical Device Guidance Documents

.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

.

————————

Media Inquiries: Michelle Bolek, 301-796-2973, Michelle.Bolek@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

———————-

.

www.QDSyringeSystems.com
www.QDSS.co
www.Twitter.com/QDSyringe
www.SafetySyringe.cc

How to Report a Medical Device Problem

What is Medical Device Reporting (MDR)?

Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. If you are a consumer or health professional you should use the nearby link to the MedWatch program for reporting significant adverse events or product problems with medical products.

User Facilities and MDR

User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.

There is a guidance for user facilities, “Medical Device Reporting for User Facilities”.  See its nearby link.

Note: Please do not send the actual device to FDA as stated in Block D9 of the MEDWATCH 3500A form. In Block D9 indicate that you are keeping the device or returning it to the manufacturer.

History of MDR Regulation

Legislation requiring device user facility reporting was enacted by Congress to increase the amount of information the Food and Drug Administration (FDA) and device manufacturers receive about problems with medical devices. Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous reports have shown there is widespread underreporting. A 1986 General Accounting Office (GAO) study showed that less than one percent of device problems occurring in hospitals are reported to FDA, and the more serious the problem with a device, the less likely it was to be reported. A GAO followup study in 1989 concluded that despite full implementation of the Medical Device Reporting (MDR) regulation, serious shortcomings still existed.

Under the Safe Medical Devices Act of 1990 (SMDA), device user facilities must report device-related deaths to the FDA and the manufacturer, if known. Device user facilities must also report device-related serious injuries to the manufacturer, or to the FDA if the manufacturer is not known. In addition, SMDA also required that device user facilities submit to FDA, on a semiannual basis, a summary of all reports submitted during that time period. The device user facility reporting section of SMDA became effective on November 28, 1991.

To implement SMDA, FDA published a tentative final rule in the Federal Register on November 26, 1991, and invited comments on the regulation. Over 300 comments were received by FDA. Then, on June 16, 1992, the President signed into law the Medical Devices Amendments of 1992 (Public Law 102-300; the Amendments of 1992), amending certain provisions (section 519 of the Food, Drug, and Cosmetic Act) relating to reporting of adverse events. The primary impact of the 1992 Amendments on device user facility reporting was to clarify certain terms and to establish a single reporting standard for device user facilities, manufacturers, importers, and distributors. A final rule published in the Federal Register on December 11, 1995, addresses the comments received by the FDA and the changes mandated by the Amendments of 1992.

Update on FDAMA

The Food and Drug Administration Modernization Act (FDAMA) was signed on 11/21/97 and became effective on 2/19/98. There were four changes that affected MDR:

  • Manufacturers and distributors/importers do not need to submit annual certification.
  • Domestic distributors are no longer required to file MDR reports, but must continue to maintain complaint files. [Importers (initial distributors for devices manufactured overseas and imported into the USA) must continue to file MDR reports.]
  • User facilities must now file an annual report instead of semiannual reports to summarize their adverse event reports.
  • Sentinel reporting by user facilities was proposed.
    The MDR regulation was revised on 1/26/2000 and 5/8/2000 to incorporate the changes under FDAMA

See the nearby link to amendments to the MDR regulation that implemented FDAMA changes, effective March 27, 2000.

____________________________________________________

www.QDSyringeSystems.com
www.QDSS.co
www.Twitter.com/QDSyringe
www.SafetySyringe.cc