[Federal Register Volume 64, Number 29 (Friday, February 12, 1999)]
[Pages 7197-7198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3437]



Food and Drug Administration
[Docket No. 98D-0132]

FDA Modernization Act of 1997: Guidance on Medical Device 
Tracking; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the revised final guidance entitled ``Guidance on 
Medical Device Tracking.'' It replaces the previous final guidance 
issued on March 4, 1998. This revised final guidance provides 
guidelines to manufacturers and distributors concerning their 
responsibilities for medical device tracking under the Federal Food, 
Drug, and Cosmetic Act (the act) as amended by the Food and Drug 
Administration Modernization Act of 1997 (FDAMA).

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the revised final guidance entitled ``Guidance on Medical 
Device Tracking'' to the Division of Small Manufacturers Assistance 
(HFZ-220), Center for Devices and Radiological Health, 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. Submit written comments 
on ``Guidance on Medical Device Tracking'' to the contact person 
(address below). See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Chester T. Reynolds, Center for 
Devices and Radiological Health (HFZ-300), Food and Drug 
Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4618.


I. Background

    Section 211 of FDAMA (Pub. L. 105-115) amended the tracking 
provisions of section 519(e) of the act (21 U.S.C. 360i(e)) to 
authorize FDA, at its discretion, to issue orders that require a 
manufacturer to track a class II or class III device if the failure of 
the device would be reasonably likely to have serious adverse health 
consequences, or the device is intended to be implanted in the human 
body for more than 1 year, or is life sustaining or life supporting and 
used outside a device user facility. The FDAMA tracking provisions 
became effective on February 19, 1998.
    On January 15, 1998, FDA conducted a public meeting to discuss 
FDAMA changes in section 519(e) of the act. Comments were received 
concerning factors FDA should consider in determining what devices are 
subject to FDAMA tracking requirements. On February 11, 1998, FDA 
issued tracking orders, under the revised FDAMA tracking provisions 
which became effective on February 19, 1998, to manufacturers of 
devices that were subject to tracking previously under the Safe Medical 
Devices Act of 1990 (the SMDA) provisions (21 CFR 821.20(b)(1), (b)(2), 
and (c)). Additionally, tracking orders were issued to manufacturers of 
intraocular lenses and arterial stents that had not been subject to 
tracking under the SMDA provisions (63 FR

[[Page 7198]]

10638, March 4, 1998). Tracking orders were also issued on December 14, 
1998, to tissue banks that manufacture and distribute dura mater.
    On March 4, 1998, FDA announced the availability of the ``Guidance 
on Medical Device Tracking'' (63 FR 10638 at 10640). This final draft 
guidance was issued as a Level 1 guidance under the agency's Good 
Guidance Practices (GGP's) (62 FR 8961, February 27, 1997). The 
guidance explained: (1) Revised tracking criteria in section 519(e) of 
the act, as amended by FDAMA; (2) patients' rights to refuse 
information disclosure; (3) FDA's discretion in issuing tracking 
orders; (4) FDA's review and reconsideration of devices subject to 
FDAMA tracking criteria; and (5) the regulatory application of tracking 
requirements in 21 CFR part 821.
    Through the January 1998 meeting and the March 1998 Federal 
Register notices, FDA solicited public comment on what factors in 
addition to the revised statutory criteria the agency should consider 
in exercising its discretion to require, or not to require, the 
tracking of devices. As a consequence of these comments, FDA believes 
it should consider the following factors, as ascertained from available 
premarket and postmarket information, in determining whether to issue a 
tracking order for a particular type of device: (1) Likelihood of 
sudden, catastrophic failure; (2) likelihood of significant adverse 
clinical outcome; and (3) need for prompt professional intervention.
    This revised final guidance replaces the March 1998 guidance and 
reflects the factors FDA may consider in determining which devices 
should be tracked. The list of tracked devices identified in the March 
1998 guidance also has been revised in this final guidance, based on 
the additional factors noted previously and identifies 14 categories of 
devices that have been released from FDAMA tracking requirements under 
the tracking requirement rescission orders issued by FDA in August 
1998. It also identifies the 16 categories of devices currently subject 
to tracking orders. The agency added one category, dura mater, which 
was the subject of tracking orders issued by the agency which became 
effective on December 14, 1998. The remaining 15 device types were the 
subject of tracking orders issued by the agency which became effective 
on February 19, 1998. Upon further review and reconsideration, FDA has 
determined that these particular devices meet the statutory tracking 
criteria under section 519(e) of the act and, upon failure, would 
likely exhibit the factors noted previously that FDA believes warrants 
their tracking. The agency may add or remove devices from the list of 
tracked devices as a result of its review of premarket applications, 
recall data, medical device reporting, inspections, petitions, 
postmarket surveillance, or other information.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
medical device tracking requirements, as amended 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.
    The agency has adopted GGP's, which set forth the agency's policies 
and procedures for the development, issuance, and use of guidance 
documents (62 FR 8961). This guidance document is issued as a Level 1 
guidance consistent with GGP's.

III. Electronic Access

    In order to receive ``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 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 revised final 
guidance may also do so using the World Wide Web (WWW). CDRH maintains 
an entry on the WWW for easy access to information including text, 
graphics, and files that may be downloaded to a personal computer 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/ochome.html''.

IV. Comments

    Interested persons may, at any time, submit to the contact person 
(address above) written comments regarding this guidance. Such comments 
will be considered when determining whether to amend the current 
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 3, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-3437 Filed 2-11-99; 8:45 am]