'Flawed from legislative foundation': FDA June 13, 2013

510(k) Device Modifications: DecidingWhen to Submit a 510(k) for a Change to an Existing Device, June 13, 2013

The purpose of the meeting is to discuss FDA’s past, present, and future policy on 510(k) Modifications with external stakeholders. FDA seeks comment from stakeholders on different options, both in the form of submissions to the docket for the Federal Register notice associated with this meeting and in discussion during the public meeting. FDA also seeks actual examples of device modifications that industry has made in order to help the Agency develop its policy. FDA expects to discuss the following options:

1.             Potential use of risk management in 510(k) device modifications decisions – can FDA incorporate risk management into its policy on how to determine whether device modifications require new 510(k) submissions in a way that ensures appropriate and consistent decisions by industry and FDA staff?

2.             Potential reliance on design controls activities – FDA seeks proposals for how industry and FDA could utilize design control activities such as design verification and validation to ensure that device modifications are appropriately evaluated prior to marketing.

3.             Potential use of critical specifications – FDA seeks proposals on whether it could incorporate the use of critical specifications in its policy on how to determine whether devices modifications require new 510(k) submissions in a way that ensures appropriate and consistent decisions by industry and FDA staff.

4.             Potential risk-based stratification of medical devices for 510(k) modification purposes – FDA seeks input on the practicality of stratifying devices that require 510(k)s by risk, where lower risk devices would not require 510(k)s for most modifications, if those modifications are part of periodic reports submitted to the Agency.

5.             Potential periodic reporting – FDA seeks comments on the possibility of requiring periodic reporting for legally marketed 510(k) devices.

6.             Potential other solutions – FDA seeks comments on combinations of the options above, or other options not mentioned here.

Date, Time and Location

This meeting will be held on June 13, 2013 beginning at 9 a.m at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room), 
Silver Spring, MD, 20993

•                FDA Campus Information

This public meeting will also be Webcast. Persons interested in viewing the Webcast must register online by 5 p.m. on May 30, 2013. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after May 31, 2013.  If you have never attended a Connect Pro event, test your connection.  A quick overview of the Connect Pro program is also available.

Preliminary Agenda (All times are tentative)

Time	Subject
9:00 AM	Introduction
9:15 AM	FDA Presentation
10:00 AM	External Stakeholder Presentations
11:00 AM	Break
11:15 AM	External Stakeholder Presentations, continued
12:15 PM	Lunch
1:15 PM	External Stakeholder Presentations, continued
2:15 PM	Break
2:30 PM	Panel Discussion
3:45 PM	Open Comment Period
4:15 PM	FDA Close-out
4:30 PM	Adjournment

Registration to Attend the Meeting

If you wish to attend this meeting, you must register by close of business on Thursday, May 30, 2013.  

There is no fee to register for the meeting and registration will be on a first-come, first-served basis.  Early registration is recommended because seating is limited.

Comment

In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the meeting topics.  FDA would like to receive these comments by May 30, 2013, so they can be discussed during the meeting, however, comments related to this meeting will be accepted until July 13, 2013.

Regardless of attendance at the meeting, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852 or electronic comments to http://www.regulations.gov.

If you wish to make an oral presentation during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the topics defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak. FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by June 3, 2013.  If selected for presentation, any presentation materials must be emailed to Michael Ryan, Michael.ryan@fda.hhs.gov no later than June 6, 2013. No commercial or promotional material will be permitted to be presented or distributed at the meeting.

Workshop Details

Food and Beverages will be available for purchase during the breaks.

If you require special accommodations due to a disability, or need additional information regarding registration,  please contact Joyce Raines,Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5709, FAX: 301-847-8142, joyce.raines@fda.hhs.gov.

Contact Us

For questions regarding meeting content please contact:

Michael J. Ryan
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, rm. 1615
Silver Spring, MD 20993-0002
Phone: 301-796-6283,
michael.ryan@fda.hhs.gov

My comment:  FDA-2013-N-0430-0001  May 29, 2013 at 6:45pm CT

510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device

Question D: Risk-Based Stratification of Medical Devices for 510(k) Modifications Purposes

The 510(k) process is not patient centered and this omission causes patient harm.  FDA perpetuates harm by allowing the public to believe that there is scientific research/clinical study performed prior to marketing and implantation of a device.  In addition, the public believes that if a device proves defective, unsafe or ineffective (as in a consumer product failure) the harmed patient will have rights to justice and be cared for medically and financially and any future preventable harm will be stopped.  In fact, the medical provider is not legally responsible for notifying FDA if there is an adverse event with an implant, unless there is a fatality.  In addition, the FDA is not charged with providing an independent investigation of the event.  The harmed patient is charged with finding a lawyer willing to file a lawsuit (often in federal court) and risk their careers on a lawsuit that will cost them more than it will return financially (tort reform limits settlements).  The 510(k) serves to perpetuate the bureaucracy of the FDA, profit the entitled medical device industry and imperil patient safety.  Joint replacement is now the #1 category of expenditure of Medicare yet UDI’s (unique device identifiers) and post market surveillance is lagging.  The U.S. public is paying for countless unproven implanted medical devices that fail and many patients require long-term rehabilitation, often at public expense.

On July 29, 2011 the Institute of Medicine returned a FDA commissioned study report to FDA/CDRH stating

“The committee finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”

Given that the FDA/CDRH rejected this advice via FDA/CDRH Director Dr. Jeffrey Shuren’s press release (that day) stating “FDA believes that the 510(k) process should not be eliminated . . .” 

According to Barry Meier of the New York Times  “As of October 2011, some 3,500 patients had filed a lawsuit involving that (J&J DePuy metal-on-metal hip) device.

There is no data on the number of all-metal hips that have failed prematurely in this country because the outcomes of orthopedic procedures are not formally tracked by the government or private companies.”

Jane Akre, on May 24, 2013 reports on Mesh Medical Device News Desk that “21,257 Cases Filed in Federal Transvaginal Mesh Litigation.”  These harmed women have implanted surgical mesh complications that prevent them from having sexual relations, may develop auto-immune disorders, experience extreme pain, may be prevented from returning to work and normal activities for a permanently implanted failed product that was cleared via 510(k).

Stop patient harm.  Follow the IOM instructions to design a system for scientific evaluation of patient harm/risk designed for protection from dangerous and unnecessary medical device implants. 

Steven Baker (MedWatch adverse event #5009052)

Joleen Chambers  (completed training workshop for FDA/CDRHPatient Representative, September 2010)