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
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)
