[Federal Register Volume 76, Number 156 (Friday, August 12, 2011)]
[Pages 50230-50231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20575]



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.


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, 
[email protected].
    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: [email protected] 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.


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 

[[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 
    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]