[Federal Register Volume 62, Number 243 (Thursday, December 18, 1997)]
[Notices]
[Pages 66373-66374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33090]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0517]


Changes in Medical Device Tracking and Postmarket Surveillance 
Authority

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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

    The Food and Drug Administration (FDA) is announcing the following 
meeting: Changes in medical device tracking and postmarket surveillance 
authority under the Food and Drug Administration Modernization Act of 
1997. The topic to be discussed is postmarket controls, including 
tracking and/or surveillance of devices.
    Date and Time: The meeting will be held on January 15, 1998, 9 a.m. 
to 3 p.m.
    Location: The meeting will be held at the University of Maryland 
Auditorium, 9640 Gudelsky Dr., Rockville, MD.
    Contact: Casper E. Uldriks, Center for Devices and Radiological 
Health (HFZ-300), Food and Drug Administration, 2098 Gaither Rd., 
Rockville, MD 20850, 301-594-4692, FAX 301-594-4610.
    Registration and Requests for Oral Presentations: Send registration 
information (including name, title, firm name, address, telephone, and 
fax number) and written material and requests to make oral 
presentations to the contact person by January 5, 1998. Written 
comments may be submitted to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857, by January 5, 1998.
    If you need special accommodations due to a disability, please 
contact Casper E. Uldriks at least 7 days in advance of the meeting.
    Transcripts: Transcripts of the meeting may be requested in writing 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the meeting at a cost of 10 cents 
per page.
    The agency is interested in discussing the statutory changes 
concerning tracking and postmarket surveillance under the Food and Drug 
Administration Modernization Act of 1997 and whether the agency should 
develop additional criteria to use to determine whether tracking or 
postmarket surveillance requirements should be ordered by FDA. The 
agency would like to supplement the statutory criteria with additional 
nonbinding criteria to help determine which devices may need to be 
added or removed from the list of devices subject to tracking and/or 
postmarket surveillance requirements. FDA intends to publish its 
revised lists by February 19, 1998, the effective date of the new law.
    By way of example, additional criteria that would support a 
tracking order might include the likelihood of a recall, or the 
likelihood of irreversible clinical outcomes. Additional criteria that 
might not support a tracking order, for example, might include current, 
standard clinical practices that mitigate risk. Additional criteria 
that would support a postmarket surveillance order might include, for 
example, the use of a new technology or the need to assess a new public 
health issue based on measurable outcomes. Additional criteria that 
would not support a

[[Page 66374]]

postmarket surveillance order, for example, might be whether there are 
alternative postmarket data collection mechanisms to obtain the same 
kind of information about the device. The agency could use such 
criteria to guide its decision whether to impose tracking or postmarket 
surveillance in a particular case.
    The agency requests that comments or presentations be provided 
concerning the statutory requirements for medical device tracking and 
postmarket surveillance and related proposed risk assessment criteria 
which may be useful to the agency to determine whether tracking orders 
or postmarket surveillance orders should be issued for devices that 
meet the basic statutory requirements of section 519(e) or 522 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e) or 360l). The 
agency would like to encourage comments, discussion and proposals from 
the industry, the professional community, consumers, and any other 
interested parties or organizations. Written comments may be submitted 
in advance of the meeting to the Dockets Management Branch (address 
above).
    To help focus discussion, FDA requests answers to the following 
questions:
    (1) What factors (or criteria) should lead FDA to order tracking 
and/or postmarket surveillance?
    (2) What factors (or criteria) should lead FDA not to order 
tracking and/or postmarket surveillance?
    (3) Under what circumstances should FDA order both tracking and 
postmarket surveillance for a device?
    (4) Under what circumstances should FDA order tracking but not 
postmarket surveillance, or vice versa?
Electronic Access
    Additional information regarding the public meeting may be found on 
the Internet on the home page for the Center for Devices and 
Radiological Health under the ``New Items on the Internet'' section at 
www.cdrh.fda.gov. This will be an informal meeting conducted in 
accordance with 21 CFR 10.65.

    Dated: December 15, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-33090 Filed 12-15-97; 3:02 pm]
BILLING CODE 4160-01-F