[Federal Register Volume 66, Number 95 (Wednesday, May 16, 2001)]
[Notices]
[Pages 27150-27151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12226]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0191]


Medical Devices; Global Harmonization Task Force; Study Group 1; 
Working Draft ``Medical Devices Classification;'' 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 draft document entitled ``Medical Devices 
Classification.'' Study Group 1 of the Global Harmonization Task Force 
(GHTF) has prepared this document on premarket regulation of medical 
devices. This document is intended to provide information only and 
represents a harmonized proposal that may be used by governments 
developing or updating their premarket regulation schemes for medical 
devices. This draft document is not being issued as an FDA guidance. 
Elements of the approach set forth in this document may not be 
consistent with current U.S. regulatory requirements. However, FDA is 
publishing the draft at this time to give the public an opportunity to 
comment on the document before the agency resumes discussions with 
other countries. Public comments will help FDA decide whether and how 
the agency can adapt these recommendations to our own regulatory 
requirements.

DATES: Submit written comments concerning this at any time. FDA must 
submit its comments on this draft to GHTF by July 1, 2001. FDA will 
consider any comments that it receives after it prepares its comments 
for GHTF in future discussions with GHTF on this issue.

ADDRESSES: Submit written comments on the document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the document. Submit 
written requests for single copies on a 3.5" diskette of the draft 
document entitled ``Medical Devices Classification'' 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.

FOR FURTHER INFORMATION CONTACT: Kathy M. Poneleit, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-3084.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has participated in a number of activities to promote the 
international harmonization of regulatory requirements. The GHTF was 
established in 1992 to facilitate medical device harmonization. 
Subsequent meetings have been held on a yearly basis in various 
locations throughout the world. The most recent GHTF meeting was held 
in September 2000, in Ottawa, Canada. The GHTF is a voluntary 
consortium of representatives from medical device regulatory 
authorities and trade associations from around the world, including 
Canada, Japan, and the European Union.
    The objective of the GHTF is to encourage harmonization of 
regulatory systems for medical devices in order to facilitate trade 
while recognizing the right of participating members to enforce 
regulatory requirements considered most suitable to protect the public 
health of their citizens. One of the ways this objective is achieved is 
by identifying and developing areas of international cooperation that 
can reduce differences in systems established to regulate medical 
devices. In an effort to accomplish these objectives, the GHTF has 
formed four study groups to draft documents and carry on other 
activities designed to facilitate global harmonization. This notice is 
a result of documents that have been developed by Study Group 1.
    Study Group 1 was formed in January 1993, and was originally tasked 
with identifying differences between various premarket regulatory 
systems. In 1995, the group was asked to propose areas of potential 
harmonization for premarket device regulations and offer guidance that 
could help lead to harmonization. As a result of their efforts, this 
group has developed the document entitled ``Medical Devices 
Classification.'' This GHTF document suggests some general guidelines 
for classification of medical devices to encourage harmonization. It 
recommends that there is a need to classify medical devices based on 
their risk to patients, users, and other persons; and that there is a 
benefit for manufacturers and regulatory authorities if a globally 
harmonized classification system is developed. The

[[Page 27151]]

classification framework presumes that the risk presented by a 
particular device depends on its intended purpose and the effectiveness 
of the risk management techniques applied during the design, 
manufacture, and use of that device. The document also suggests that 
the regulatory controls applied should be proportional to the level of 
risk associated with a medical device and should increase with the 
associated degree of risk presented by the medical device. The GHTF 
document suggests four global classifications of devices.
    This document also presents a decision tree logic that may help 
regulatory authorities develop different parameters that might be used 
to classify specific devices.
    When FDA discusses draft documents with representatives of other 
countries, we seek public comment on the resulting documents. We 
believe that it is important to publish draft documents for comment at 
the same time as other countries so we may review the public comments 
and resume discussions in a timely manner. Because other countries do 
not follow our good guidance practices (GGPs), we do not require draft 
documents that result from international discussions to comply with the 
format requirements of our GGP regulation. The GGP regulation does 
require that any final FDA guidance that results from international 
discussions will comply with the GGP regulation.

II. Electronic Access

    In order to receive ``Medical Devices Classification'' via your fax 
machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-
827-0111 from a touch-tone telephone. Press 1 to enter the system. At 
the second voice prompt press 1 to order a document. Enter the document 
number (1327) followed by the pound sign (#). Follow the remaining 
voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft document 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 Internet access. Updated 
on a regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, 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.

III. Comments

    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments regarding this draft 
guidance. FDA must submit its written comments to the GHTF by July 1, 
2001. FDA will consider any comments that it receives in a timely 
manner, while preparing those comments. FDA will consider any public 
comments that it receives after preparation of its comments to GHTF in 
future discussions on this issue. Submit two copies of any comments, 
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: May 7, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-12226 Filed 5-15-01; 8:45 am]
BILLING CODE 4160-01-S