E8-16000. Global Harmonization Task Force, Study Groups 1 and 3; Proposed and Final Documents; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of final and proposed documents that have been prepared by Study Groups 1 and 3 of the Global Harmonization Task Force (GHTF), respectively. These documents represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe FDA's current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. In particular, FDA seeks comments on the advantages and disadvantages of the approaches in the GHTF documents, particularly where they are not consistent with current practices for the manufacturer of products distributed within the United States.

DATES:

Submit written or electronic comments on these documents by October 14, 2008. After October 14, 2008, written comments or electronic comments may be submitted at any time to the contact persons listed in this document.

ADDRESSES:

Submit written requests for single copies of these documents to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the Supplementary Information section for information on electronic access to the documents.

Submit written comments concerning these documents to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.reguations.gov. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

For information regarding Study Group 1: Ginette Y. Michaud, Chairperson, GHTF, Study Group 1, Office of Device Evaluation, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3700.

For information regarding Study Group 3: Kimberly Trautman, GHTF, Study Group 3, Office of Compliance, Center for Devices and Radiological Health (HFZ-340), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240-276-0296.

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. This meeting led to the development of the organization now known as the GHTF to facilitate harmonization. Subsequent meetings have been held in various locations throughout the world.

The GHTF is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. Since its inception, the GHTF has been comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia-Pacific, and North America, each of which actively regulates medical devices using their own unique regulatory framework.

The objective of the GHTF is to encourage convergence at the global level of regulatory systems of medical devices 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 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 formed five study groups to draft documents and carry on other activities designed to facilitate global harmonization. This notice relates to documents that have been developed by two of the Study Groups (1 and 3).

Study Group 1 was initially tasked with the responsibility of identifying differences between various regulatory systems. In 1995, the group was asked to propose areas of potential harmonization for premarket device regulations and possible guidelines that could help lead to harmonization. As a result of its efforts, this group has developed final document GHTF/SG1/N011:2008. GHTF/SG1/N011:2008 “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)” is intended to provide information on the content of the STED to be assembled and submitted to a Regulatory Authority (RA) or Conformity Assessment Body (CAB) for premarket review, and for use postmarket to assess continuing conformity to GHTF Study Group 1's document, GHTF/SG1/N41R9:2005, “Essential Principles of Safety and Performance.”

Study Group 3 was initially tasked with the responsibility of developing documents on Quality Systems. As a result of their efforts, this group has developed proposed document SG3(PD)N17R7. The proposed document SG3(PD)N17R7 entitled, “Quality Management System—Medical Devices—Guidance on the Control of Products and Services Obtained From Suppliers” provides information for medical device manufacturers on control of products and services obtained from suppliers.

II. Significance of Documents

These documents represent recommendations from the GHTF study groups and do not describe regulatory requirements. FDA is making these documents available so that industry and other members of the public may express their views and opinions. In particular, FDA seeks comments on the advantages and disadvantages of the approaches in the GHTF documents, particular where they are not consistent with current practices for the manufacturer of products distributed in the United States.

III. Electronic Access

Persons interested in obtaining a copy of these documents may do so by using the Internet. The Center for Devices and Radiological Health (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 device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. Information on the GHTF may be accessed at http://www.ghtf.org. The CDRH Web site may be accessed at http://www.fda.gov/​cdrh.

IV. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES), written or electronic comments regarding these documents. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov.

Dated: July 8, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.