[Federal Register Volume 64, Number 152 (Monday, August 9, 1999)]
[Notices]
[Pages 43196-43197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20367]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-2359]


Medical Devices; Global Harmonization Task Force: Summary 
Technical File Documents for Premarket Documentation of Conformity With 
Requirements for Medical Devices; Recommendations on the Role of 
Standards in the Assessment of Medical Devices; and a Recommendation on 
Medical Device 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 three documents entitled ``Summary Technical File for 
Premarket Documentation of Conformity With Requirements for Medical 
Devices;'' ``Recommendation: Role of Standards in the Assessment of 
Medical Devices;'' and ``Recommendation on Medical Devices 
Classification.'' Study group 1 of the Global Harmonization Task Force 
(GHTF) has prepared these documents on premarket regulation of medical 
devices. These documents are intended to provide information only and 
represent harmonized proposals and recommendations that may be used by 
governments developing or updating their premarket regulation schemes 
for medical devices. Elements of the approach set forth in these 
documents may not be consistent with current U. S. regulatory 
requirements. FDA is requesting comments on these documents.

DATES: Written comments by September 30, 1999. After the close of the 
comment period, written comments may be submitted at any time to Kimber 
C. Richter (address below).

ADDRESSES: Submit written comments on the documents to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with 
the docket number found in brackets in the heading of this document. If 
you do not have access to the World Wide Web (WWW), submit written 
requests for single copies on a 3.5'' diskette of the document listed 
above 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 
requests, or fax your request to 301-443-8818. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to these 
documents.

FOR FURTHER INFORMATION CONTACT: Kimber C. Richter, Office of Device 
Evaluation (HFZ-400), Center for Devices and Radiological Health, Food 
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 
301-594-2022.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has participated in a number of activities to promote the 
international harmonization of regulatory requirements. In September 
1992, a meeting was held in Nice, France, by senior regulatory 
officials to evaluate international harmonization. At this time it was 
decided to form GHTF to facilitate harmonization. Subsequent meetings 
have been held on a yearly basis in various locations throughout the 
world. The most recent GHTF meeting was held in June and July 1999, in 
Bethesda, MD, in the United States.
    The objective of the GHTF is to encourage convergence at the global 
level of regulatory systems of medical devices in order to facilitate 
trade while preserving the right of participating members to address 
the protection of public health by regulatory means considered most 
suitable. One of the ways this objective is achieved is by identifying 
and developing areas of international cooperation in order to 
facilitate progressive reduction of technical and regulatory 
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 regulatory systems. In 
1995, the group was asked to propose areas of potential harmonization 
for premarket device regulations and possible guidance that could help 
lead to harmonization. As a result of their efforts, this group has 
developed three draft documents that are described briefly in the 
following paragraphs.
    (1) ``Summary Technical File for Premarket Documentation of 
Conformity With Requirements for Medical Devices'' (GHTF.SG1.NO11R7). 
Study group 1 suggests that this document should be used with the 
document

[[Page 43197]]

entitled ``Essential Principles of Safety and Performance of Medical 
Devices on a Global Basis; Final Working Draft'' (63 FR 46227, August 
31,1998).
    This document has been developed to encourage global convergence of 
regulatory systems and provide one means of potential future 
achievement. It is intended for use by medical device regulators, 
conformity assessment bodies, and industry, and offers an economic and 
effective approach to the control of medical devices in the interest of 
public health. The document will be of value to countries developing or 
amending regulations. The regulatory requirements of some countries may 
not, at present, reflect the contents of this document.
    The purpose of this document is to propose a format and harmonized 
content for a summary technical file to be held by the sponsor or 
submitted, as required by the regulatory authority, for premarket 
clearance/approval. It proposes a format that may be used as an 
alternative to country-specific current submission formats by GHTF 
member states. This document summarizes the technical information 
needed to demonstrate conformity to premarket requirements that are 
consistent across various regulatory systems. Users of this document 
may submit it to various regulatory authorities with country specific 
additions as needed. (These will be defined in a second volume still 
under development.) Study group 1 may focus on these differences for 
future harmonization efforts. It should be noted that the amount of 
detail and information that will be needed in the summary technical 
file may vary considerably with the risk class of the product 
concerned.
    (2)``Recommendation: Role of Standards in the Assessment of Medical 
Devices'' (GHTF.SG1.NO12R7). This GHTF document provides harmonized 
guidance for regulatory authorities on the use of standards in 
premarket regulation of devices. It suggests that international 
standards may assure the safety, quality and performance of medical 
devices and should serve as the building blocks for a harmonized 
regulatory process. Additionally, it recommends that regulatory 
authorities and industry should encourage and support the development 
of international standards for medical devices to demonstrate 
compliance with the essential principles of safety and performance of 
medical devices. It suggests that the use of standards is voluntary, 
except in those particular cases where the regulatory authority has 
deemed certain standards mandatory.
    (3)``Recommendation on Medical Devices Classification.'' This GHTF 
document suggests some general guidelines for classification of medical 
devices to achieve eventual 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. This document goes on to say that there is a risk 
presented by a particular device and that the risk 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 Study Group 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.
    These documents are presented for review and comment so that 
industry and other members of the public may express their views and 
opinions on these matters.

II. Electronic Access

    Persons interested in obtaining copies of these draft documents may 
also do so using the WWW. Updated on a regular basis, the CDRH home 
page includes the document entitled ``Essential Principles for Safety 
and Performance of Medical Devices on a Global Basis; Final Working 
Draft,'' device safety alerts, (including lists of approved 
applications and manufacturers' addresses), small manufacturers' 
assistance, information on video-oriented conferencing and electronic 
submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at ``http://
www.fda.gov/CDRH''. Information on the GHTF may be accessed at http://
www.GHTF.org''.

III. Comments

    Interested persons may, on or before September 30, 1999, submit to 
the Dockets Management Branch (address above) written comments 
regarding the draft documents. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with docket number found in brackets in the heading of 
this document and with the full title of these documents. The draft 
documents and received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.
    After September 30, 1999, written comments regarding the draft 
documents may be submitted at any time to the contact person (address 
above).

    Dated: July 25, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-20367 Filed 8-6-99; 8:45 am]
BILLING CODE 4160-01-F