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APPENDIX 1

DATE: July 25, 2001

FDA Announces Pilot Premarket Submission Review Program Utilizing the Draft Global Harmonization Task Force Summary Technical Document

FDA is announcing a pilot premarket review program and is soliciting participation from the medical device industry. The pilot program is intended to evaluate the utility of a draft document entitled "Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)." The draft STED document describes an internationally harmonized format and content for premarket submissions. The Global Harmonization Task Force (GHTF), Study Group 1, developed the draft document.

The pilot premarket review program will rely on three related documents: (1) the draft STED document, (2) an FDA guidance, and (3) the GHTF document entitled "Essential Principles of Safety and Performance of Medical Devices." The FDA guidance document is intended to assist the medical device industry in completing a submission that uses the draft STED format and is consistent with United States requirements. The Essential Principles document is a key reference in the draft STED document. The draft STED document (WORD) and Essential Principles document (WORD)(GHTF reference numbers GHTF.SG1.N011R15 and GHTF.SG1.NO20R5) accompany this announcement.

The FDA pilot program is limited to PMA applications and 510(k) submissions for the specific types of medical devices identified in Table 1 of the FDA draft guidance. The pilot program will not include submissions for Special 510(k)s, Product Development Protocols, Humanitarian Device Exemptions, or submissions already reviewed by Third Parties. Two Office of Device Evaluation divisions will be the primary participants in the pilot. Two additional divisions will participate on a more limited basis as described in the guidance.

FDA encourages persons who intend to submit PMA applications or 510(k) submissions for the devices identified in Table 1 to consider participating in the pilot program. During the pilot program, the draft STED document, when used in conjunction with the FDA guidance, will be an alternative to the current format and content of submissions described in previous FDA guidance documents, except as described in the guidance for the two divisions participating on a more limited basis.

The objective of the GHTF is to encourage harmonization among regulatory systems in order to reduce regulatory burden for regulated industry and to help make new devices available more quickly to the international public. Those participating in the pilot program will help achieve these goals.

Four of the founding members of the GHTF are participating in the pilot program. They include the United States, Canada, Australia, and the European Union. Each of the participants will provide specific directions for implementing the pilot program within its jurisdiction.

The GHTF wants to assess the international utility of the draft STED document. Therefore, SG1 of the GHTF encourages manufacturers to prepare and submit, if submission is required, submissions using the STED format for the same device to as many of the four participating GHTF member countries as possible. SG1 also encourages manufacturers to try the STED format for different classes of devices that are candidates for the pilot program.

FDA intends to process premarket submissions in the GHTF harmonized format within statutory time limits and with review times comparable to other submissions for similar products. There will be no expedited review of submissions, unless the device merits such a process under current policies.

FDA plans to conduct the pilot program for one year. The pilot program will begin on the date of publication of the final FDA guidance document. FDA will assess how the pilot is proceeding during its course and may choose to decline receipt of additional submissions using the draft STED format in order to assess the initial experiences. At the end of the pilot, FDA and other GHTF participants will analyze the outcome to determine whether the draft STED document is a viable alternative to current premarket submission formats, and if the program should be continued or expanded. FDA will post in its internet web site a report of the outcome of the pilot program.

If you are interested in participating, or have questions regarding the pilot program, please contact one of the following individuals:

Timothy A. Ulatowski
(301)443-8879
tau@cdrh.fda.gov

Margie Shulman
(301)594-1190
mgs@cdrh.fda.gov

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