[Federal Register Volume 63, Number 42 (Wednesday, March 4, 1998)]
[Pages 10640-10641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5519]



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.


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 

[[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 

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 
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 

    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]