[Federal Register Volume 65, Number 15 (Monday, January 24, 2000)]
[Notices]
[Pages 3722-3723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1542]


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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, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of the revised guidance document entitled ``Guidance on 
Medical Device Tracking.'' This guidance document, which replaces the 
previous guidance issued on February 12, 1999, 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:  Submit written comments at any time.

ADDRESSES:  Submit written requests for single copies on a 3.5" 
diskette of the guidance document 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.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 211 of FDAMA (Public Law 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: (1) The 
failure of the device would be reasonably likely to have serious 
adverse health consequences; (2) the device is intended to be implanted 
in the body for more than 1 year; or (3) the device is life sustaining 
or life supporting and used outside a device user facility. The FDAMA 
tracking provisions became effective on February 19, 1998.
    The revised final guidance replaces the February 1999 guidance and 
clarifies the devices that must be tracked. Agency experience indicates 
that industry and other interested parties are confused about the term 
``replacement heart valves'' because there is more than one type. The 
category of replacement heart valves that must be tracked is limited to 
mechanical heart valves only and does not include human allograft 
(tissue) heart valves. The revised guidance document includes this 
descriptive limitation.
    Agency experience also indicates that industry and other interested 
parties are confused about which infusion pumps are subject to medical 
device tracking because the types of fluids the pumps are intended to 
deliver may not be clear from indications for use set out in labeling. 
The previous guidance stated that infusion pumps, except those 
designated and labeled for use

[[Page 3723]]

exclusively for fluids with low potential risks, such as enteral 
feeding or anti-infectives, were subject to tracking. The agency has 
reevaluated the types of infusion pumps subject to tracking and the 
best way to describe them in the guidance document. The revised 
guidance explains that tracking is required only for electromechanical 
infusion pumps that are used outside a user facility. This was the 
agency's position in 1993 when tracking was originally implemented (58 
FR 43442 at 43449). The phrase ``electromechanical only'' will be used 
to describe the pumps rather than a reference to the classification 
regulation. FDA believes this will clarify the guidance because the 
terms used in the classification language for infusion pumps may 
include types that do not require tracking.
    Finally, the agency added abdominal aortic aneurysm stent grafts to 
the devices that must be tracked. The agency issued tracking orders for 
these devices on September 28, 1999, which were effective immediately. 
FDA determined that these devices meet the statutory tracking criteria 
under section 519(e) of the act because failure of the device would be 
reasonably likely to have serious adverse health effects. 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 Good Guidance Practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This guidance document is issued as a Level 2 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 guidance may also do 
so using the Internet. CDRH maintains an entry on the Internet for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with access to the Internet. 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.

    Dated: January 9, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-1542 Filed 1-21-00; 8:45 am]
BILLING CODE 4160-01-F