[Federal Register Volume 63, Number 42 (Wednesday, March 4, 1998)]
[Notices]
[Pages 10640-10641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5519]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0132]
FDA Modernization Act of 1997: Guidance on Medical Device
Tracking; Availability
AGENCY: Food and Drug Administration
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance on Medical Device
Tracking.'' This guidance is intended to provide guidelines to
manufacturers and distributors about their responsibilities for medical
device tracking under the Food, Drug and Cosmetic Act (the act), as
amended by the Food and Drug Administration Modernization Act (FDAMA).
This guidance addresses what statutory and regulatory tracking
requirements have changed and what requirements remain the same under
the FDAMA amendments. The agency requests comments on this guidance.
Elsewhere, in this issue of the Federal Register, FDA is announcing new
orders to manufacturers of devices that were subject to tracking.
DATES: Written comments concerning this guidance must be received by
May 4, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857. Comments should be identified with the docket
number found in brackets in the heading of this document. Submit
written requests for single copies of the ``Guidance on Medical Device
Tracking'' (available on 3.5'' diskette) to the Division of Small
Manufacturers Assistance, Center for Devices and Radiological Health
(HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville,
MD 20850. Send two self-addressed adhesive labels to assist that office
in processing your request, or fax your request to 301-443-8818. See
the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance.
FOR FURTHER INFORMATION 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.
SUPPLEMENTARY INFORMATION:
I. Background
Section 211 of the Food and Drug Administration Modernization Act
(Pub. L. 105-115) (FDAMA) amended the tracking provisions of section
519(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
360i(e)), authorizing FDA to order manufacturers to track devices
meeting criteria established under FDAMA. These amendments became
effective on February 19, 1998. This guidance explains device tracking
under section 519(e) of the act, as amended by FDAMA, including: (1)
Changes in the criteria requiring devices to be tracked; (2) the rights
of patients to refuse to disclose identifying information; (3) the
discretion FDA has in issuing tracking orders; (4) FDA review and
reconsideration of devices meeting tracking criteria; and (5) the
application of certain requirements in the agency's existing tracking
regulations in 21 CFR part 821.
This guidance represents the agency's current thinking on medical
device
[[Page 10641]]
tracking under tracking provisions revised by FDAMA. It does not create
or confer any rights for, or on, any person and does not operate to
bind FDA or the public. An alternative approach may be used if such
approach satisfies the applicable statute, regulations, or both. This
is a Level 1 guidance. Public comment prior to implementation of this
guidance document is not required because the guidance is needed to
implement new statutory tracking requirements enacted by FDAMA. The
agency is providing for a comment period of 60 days after the date of
publication of the Federal Register notice of availability for the
document.
II. Electronic Access
In order to receive the guidance entitled ``Guidance on Medical
Device Tracking'' via your fax machine, call the CDRH Facts-On-Demand
(FOD) system at 800.899.0381 or 301.827.0111 from a touch-tone
telephone. At the first voice prompt press 1 to access DSMA Facts, at
the second voice prompt press 2, and then enter the document number
(169) followed by the pound sign (#). Then follow the remaining voice
prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so by using the World Wide Web (WWW). The Center for Devices and
Radiological Health (CDRH) maintains an entry on the WWW for easy
access to information including text, graphics, and files that may be
downloaded to a PC with access to the WWW. Updated on a regular basis,
the CDRH Home Page includes ``Guidance on Medical Device Tracking,''
device safety alerts, Federal Register reprints, information on
premarket submissions (including lists of approved applications and
manufacturers' addresses), small manufacturers' assistance, information
on video conferencing and electronic submissions, mammography matters,
and other device-oriented information. The CDRH home page may be
accessed at http://www.fda.gov/cdrh. ``Guidance on Medical Device
Tracking'' will be available at http://www.fda.gov/cdrh.
A text-only version of the CDRH Web site is also available from a
computer or VT-100 compatible terminal by dialing 800-222-0185
(terminal settings are 8/1/N). Once the modem answers, press Enter
several times and then select menu choice 1: FDA BULLETIN BOARD
SERVICE. From there follow instructions for logging in, and at the BBS
TOPICS PAGE, arrow down to the FDA home page (do not select the first
CDRH entry). Then select Medical Devices and Radiological Health. From
there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general
information, or arrow down for specific topics.
III. Comments
Interested persons may, by or before May 4, 1998 submit to the
Dockets Management Branch (address above) written comments regarding
this guidance. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. The guidance document and received comments may be seen in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: February 25, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-5519 Filed 2-27-98; 3:14 pm]
BILLING CODE 4160-01-F