Medical Devices: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled “A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff.” The revised guidance extends the voluntary pilot premarket review program Summary Technical Documentation (STED pilot) until we have received an adequate number of submissions to evaluate the STED pilot. The pilot program is intended for evaluating the utility of an alternative submission procedure.
Table of Contents Back to Top
DATES: Back to Top
Submit written or electronic comments on the guidance at any time.
ADDRESSES: Back to Top
Submit written requests for single copies on a 3.5” diskette of the guidance document entitled “A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff” 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 301-443-8818. See SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.
Submit written comments concerning this guidance 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.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Back to Top
Harry R. Sauberman, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-4879, or Kenneth J. Cavanaugh Jr., Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8517.
SUPPLEMENTARY INFORMATION: Back to Top
I. Background Back to Top
In the Federal Register of June 26, 2003 (68 FR 38068), FDA announced the availability of a guidance document entitled “A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff.” The guidance document announced a pilot program for a premarket review program and encouraged participation from the medical device industry. The pilot program is intended to evaluate the utility of an alternative submission procedure as described in the draft STED document prepared by Study Group 1 of the Global Harmonization Task Force (GHTF). The document seeks to harmonize the different requirements for premarket submissions in various countries.
The June 26, 2003, guidance and notice of availability announced that the pilot program would be in effect for 1 year from the date of publication of the notice of availability. In the Federal Register of July 23, 2004 (69 FR 44040), the pilot program was subsequently extended until June 25, 2005. FDA has received no comments on the guidance issued on June 26, 2003, or the updated version published on July 23, 2004. In this revised guidance, FDA is extending the pilot program until we have received a sufficient number of submissions to evaluate the pilot program. In addition, FDA is updating the contact information and the references to the GHTF documents, along with other minor editorial changes. The FDA guidance document is intended to assist the medical device industry in making submissions to FDA that use a proposed internationally harmonized format and content for premarket submissions, e.g., premarket approval applications and 510(k) submissions in the United States. The revised guidance is a level 2 guidance under FDA's good guidance practices (GGPs) regulation (21 CFR 10.115). FDA made the guidance available on its Web site at http://www.fda.gov/cdrh/ode/guidance/1347.html.
The GHTF is a voluntary group comprised of medical device regulatory officials and industry representatives from the United States, Canada, Australia, the European Union, and Japan. The goals of the GHTF include the following items: (1) Encourage convergence in regulatory practices with respect to ensuring the safety, effectiveness, performance, and quality of medical devices; (2) promote technological innovation; and (3) facilitate international trade. GHTF provides further information concerning the structure, goals, and procedures at the GHTF Web site and can be accessed at http://ghtf.org.
II. Significance of Guidance Back to Top
This guidance is being issued consistent with FDA's Good Guidance Practice (GGP) regulation (21 CFR 10.115). The guidance represents the agency's current thinking on the GHTF recommendations as related to premarket submission to FDA. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
III. Electronic Access Back to Top
To receive a copy of “A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff,” by fax call 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 (1347) followed by the pound sign #. Follow the remaining voice prompts to complete your request.
To receive “A Pilot Program to Evaluate a Proposed Globally Harmonised Alternative for Premarket Procedures; Guidance for Industry and FDA Staff,” you may either send a fax request to 301-443-8818 to receive a hard copy of the document, or send an e-mail request to firstname.lastname@example.org to receive a hard copy or an electronic copy. Please use the document number 1347 to identify the guidance you are requesting.
Persons interested in obtaining a copy of the guidance may also do so by 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: Device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's, information on video conferencing, and electronic submissions, Mammography Matters, and other device-related information. The CDRH web site home page may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.
IV. Comments Back to Top
Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed 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. Comments received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: November 2, 2005.
Assistant Commissioner for Policy.
[FR Doc. 05-22387 Filed 11-9-05; 8:45 am]
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