
[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Notices]
[Pages 52742-52743]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21434]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0359]


Public Meeting--Strengthening the National Medical Device 
Postmarket Surveillance System; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public meeting entitled ``Public Meeting--Strengthening the 
National Medical Device Postmarket Surveillance System.'' The purpose 
of the meeting is to solicit public feedback regarding the medical 
device postmarket surveillance system in the United States.

DATES: The public meeting will be held on September 10, 2012, from 9 
a.m. to 4 p.m.

ADDRESSES: The public meeting will be held at the Greenbelt Marriott 
Hotel, 6400 Ivy Lane, Greenbelt, MD 20770, 301-441-3700.

FOR FURTHER INFORMATION CONTACT: Anita Rayner, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3316, Silver Spring, MD 20993, 301-796-6002, email: 
Anita.Rayner@fda.hhs.gov; or Danica Marinac-Dabic, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4110, Silver Spring, MD 20993, 301-796-
6689, email: Danica.Marinac-Dabic@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Registration: Registration is free and 
available on a first-come, first-served basis. Persons interested in 
attending this public meeting must register online by 5 p.m., September 
10, 2012. Early registration is recommended because facilities are 
limited and, therefore, FDA may limit the number of participants from 
each organization. If time and space permits, onsite registration on 
the day of the meeting will be provided beginning at 8 a.m.
    If you need special accommodations due to a disability, please 
contact Joyce Raines Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4319, 
Silver Spring, MD 20993, 301-796-5709, email: joyce.raines@fda.hhs.gov 
no later than September 5, 2012.
    To register for the public meeting, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this public meeting from the posted events list.) Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone number. Those without 
Internet access should contact Danica Marinac-Dabic (see Contact 
Person) to register. Registrants will receive confirmation after they 
have been accepted. You will be notified if you are on a waiting list.
    Streaming Webcast of the Public Meeting: This meeting will also be 
Webcast. Persons interested in viewing the Webcast must register online 
by 5 p.m., September 5, 2012. Early registration is recommended because 
Webcast connections are limited. 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 September 7, 2012.
    Requests for Oral Presentations: This public meeting includes a 
public comment session and a moderated discussion session. During 
online registration, you may indicate if you wish to present during a 
public comment session or participate in a specific session, and which 
topics you wish to address. FDA has included

[[Page 52743]]

general topics in this document. FDA will do its best to accommodate 
requests to make public comment. Individuals and organizations with 
common interests are urged to consolidate or coordinate their 
presentations and request time for a joint presentation, or submit 
requests for designated representatives to participate in the focused 
sessions. Following the close of registration, FDA will determine the 
amount of time allotted to each presenter and the approximate time each 
oral presentation is to begin and will notify participants by September 
4, 2012. All requests to make oral presentations must be received by 
August 31, 2012. Any presentation materials must be emailed (see 
Contact Person) no later than September 5, 2012. No commercial or 
promotional material will be permitted to be presented or distributed 
at the meeting.
    Comments: FDA is holding this public meeting to solicit public 
feedback regarding the medical device postmarket surveillance system in 
the United States. 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. The deadline for 
submitting comments related to this meeting is October 9, 2012.
    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. It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, when responding to specific 
questions as outlined in section II of this document, please identify 
the question you are addressing. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcripts: 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 (see Comments). 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 the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. A link to the transcripts will also be available 
approximately 45 days after the meeting on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this meeting from the posted events list.)

I. Background

    FDA's Center for Devices and Radiological Health (CDRH) is 
responsible for protecting the public health by assuring the safety and 
effectiveness of medical devices and safe radiation-emitting products. 
A key part of this mission is to monitor medical devices and 
radiological products for continued safety and effectiveness after they 
are in use and to help the public get the accurate, science-based 
information they need to improve their health.
    Several high-profile device performance concerns have led some to 
question whether CDRH's current postmarket surveillance system is 
optimally structured to meet the challenges of rapidly evolving medical 
devices and the changing nature of health care delivery and information 
technology. In their report entitled ``Medical Devices and the Public's 
Health: The FDA 510(k) Clearance Process at 35 Years'' published in 
July 2011, the Institute of Medicine recommended that FDA develop and 
implement a comprehensive medical device postmarket surveillance 
strategy to collect, analyze, and act on medical device postmarket 
performance information. As part of the process of developing and 
implementing this strategy, FDA is holding a public meeting to discuss 
the current and future state of medical device postmarket surveillance. 
Prior to this public meeting, FDA intends to issue a preliminary report 
on CDRH's plan to strengthen the medical device postmarket surveillance 
system in the United States. FDA intends to solicit public feedback 
regarding the report contents.

II. Topics for Discussion at the Public Meeting

    We intend to solicit public feedback regarding the medical device 
postmarket surveillance system in the United States. Specific topics of 
interest include, but are not limited to, the following: (1) The unique 
device identifier system and its incorporation into health-related 
electronic records; (2) national and international device registries 
for selected products; (3) adverse event reporting and analysis; and 
(4) developing and using new methods for evidence generation synthesis 
and appraisal. These topics will also be discussed in relation to the 
Sentinel provision in the FDA Safety and Innovation Act calling for the 
expansion of the postmarket risk identification and analysis system to 
include devices. Key questions for feedback include:
     Are these the right efforts?
     What principles should drive these efforts?
     What are the attributes of an effective ``active 
surveillance'' system for devices?
     How can the device active surveillance system leverage 
existing systems (e.g., Sentinel)?
    Following public comment, FDA intends to have a moderated 
discussion session regarding strengthening the national medical device 
postmarket surveillance system.

    Dated: August 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-21434 Filed 8-27-12; 4:15 pm]
BILLING CODE 4160-01-P


