[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]
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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.
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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