[Federal Register Volume 76, Number 156 (Friday, August 12, 2011)]
[Notices]
[Pages 50230-50231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20575]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0556]
Center for Devices and Radiological Health 510(k) Clearance
Process; Recommendations Proposed in Institute of Medicine Report:
``Medical Devices and the Public's Health, The FDA 510(k) Clearance
Process at 35 Years;'' Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled: ``Recommendations Proposed in Institute of Medicine
Report: `Medical Devices and the Public's Health, The FDA 510(k)
Clearance Process at 35 Years.' '' The purpose of the public meeting is
to encourage public comment on the recommendations proposed in the
Institute of Medicine (IOM) report.
Date and Time: The public meeting will be held on September 16,
2011, from 8:30 a.m. to 5 p.m. Submit electronic and written comments
by September 30, 2011.
Location: The public meeting will be held at the Silver Spring
Hilton Hotel, 8727 Colesville Rd., Silver Spring, MD 20910.
Contact Person: Philip Desjardins, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5452, Silver Spring, MD 20993, 301-796-5678,
philip.desjardins@fda.hhs.gov.
Registration and Requests for Oral Presentations: Registration is
free and will be on a first-come, first-served basis. Persons
interested in attending this meeting must register online by 5 p.m. on
September 15, 2011. For those without Internet access, please call the
contact person to register.
Early registration is recommended because seating is limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permit, onsite registration on the day
of the public meeting will be provided beginning at 7:30 a.m.
If you need special accommodations due to a disability, please
contact Susan Monahan (email: Susan.Monahan@fda.hhs.gov or phone: 301-
796-5661) no later than September 15, 2011.
To register for the public meeting, please visit http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm
(or go to the FDA Medical Devices News & Events--Workshops &
Conferences calendar and select this public meeting from the posted
events list). Please provide complete contact information for each
attendee, including name, title, affiliation, address, email,
telephone, and FAX number. Registrants will receive confirmation once
they have been accepted. You will be notified if you are on a waitlist.
This meeting includes a public comment session. During online
registration you may indicate if you wish to make an oral presentation
during a public comment session at the public meeting, and which topic
you wish to address in your presentation. FDA has included topics for
comment in this document. FDA will do its best to accommodate requests
to speak. Individuals and organizations with common interests are urged
to consolidate or coordinate their presentations, and request time for
a joint presentation. FDA will determine the amount of time allotted to
each presenter and the approximate time each oral presentation is to
begin. All requests to make oral presentations, as well as presentation
materials, must be sent to the contact person by September 15, 2011.
Comments: Regardless of attendance at the public meeting,
interested persons may submit either electronic or written comments
until September 30, 2011. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
SUPPLEMENTARY INFORMATION:
I. What is the background and purpose for holding this public meeting?
In September 2009, FDA's Center for Devices and Radiological Health
(CDRH) convened an internal 510(k) Working Group as part of a two-
pronged, comprehensive assessment of the premarket notification
(510(k)) process. The first prong of this evaluation consisted of an
internal evaluation of the 510(k) process, resulting in the publication
of the CDRH preliminary internal evaluation entitled ``510(k) Working
Group Preliminary Report and Recommendations'' (http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM220784.pdf ).
This preliminary report was intended to communicate preliminary
findings and recommendations regarding the 510(k) program and actions
CDRH might take to address identified areas of concern. The report was
issued on August 5, 2010 (75 FR 47307). After reviewing public comment,
CDRH issued a plan of action for implementation of the previously
announced
[[Page 50231]]
recommendations on January 19, 2011 (http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM239450.pdf ).
The second prong of the comprehensive assessment of the 510(k)
process was an independent study by the IOM. At the request of FDA, IOM
evaluated the 510(k) clearance process and made recommendations aimed
at protecting the health of the public and making available a mechanism
to achieve timely access of medical devices to the market. On July 29,
2011, IOM released the report ``Medical Devices and the Public's
Health, The FDA 510(k) Clearance Process at 35 Years'' (report) (http://www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx). The report contains eight
recommendations aimed at improving regulation of medical devices. The
recommendations are the subject of this public meeting.
II. What are the specific issues for discussion and public comment at
the public meeting?
FDA welcomes comments on the following recommendations provided in
the IOM report:
1. The Food and Drug Administration should obtain adequate
information to inform the design of a new medical device regulatory
framework for class II devices so that the current 510(k) process, in
which the standard for clearance is substantial equivalence to
previously cleared devices, can be replaced with an integrated
premarket and postmarket regulatory framework that effectively provides
a reasonable assurance of safety and effectiveness throughout the
device life cycle. Once adequate information is available to design an
appropriate medical device regulatory framework, Congress should enact
legislation to do so.
2. FDA should develop and implement a comprehensive strategy to
collect, analyze, and act on medical device postmarket performance
information.
3. FDA should review its postmarket regulatory authorities for
medical devices to identify existing limitations on their use and to
determine how the limitations can be addressed.
4. FDA should investigate the viability of a modified de novo
process as a mechanism for evaluating the safety and effectiveness of
class II devices.
5. FDA should develop and implement a program of continuous quality
improvement to track regulatory decisions on medical devices, identify
potential process improvements in the medical device regulatory
framework, and address emerging issues that affect decisionmaking.
6. FDA should commission an assessment to determine the effect of
its regulatory process for class II devices on facilitating or
inhibiting innovation in the medical device industry.
7. FDA should develop procedures that ensure the safety and
effectiveness of software used in devices, software used as devices,
and software used as a tool in producing devices.
8. FDA should promptly call for PMA applications for or reclassify
class III devices that remain eligible for 510(k) clearance.
III. Where can I find out more about this public meeting?
Background information on the public meeting, registration
information, the agenda, information about lodging, transcripts, and
other relevant information will be posted, as it becomes available, on
the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
IV. Will there be transcripts of the meeting?
Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.
Dated: August 9, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-20575 Filed 8-11-11; 8:45 am]
BILLING CODE 4160-01-P