[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
