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Product Development Protocol

General Information Resources Contacts

General Information

As part of its reengineering initiative, the Food and Drug Administration, Center for Devices and Radiological Health is proposing to implement the statutory authority for Product Development Protocol (PDP). Section 515(f) of the Food, Drug, and Cosmetic Act provides this alternative process to the premarket approval process (PMA) for class III devices . This alternative process, (PDP), was not implemented during the early years of the device program because it was considered potentially complex and there was a need to focus attention on implementing the core provisions of the Medical Device Amendments of 1976 such as the IDE, PMA, 510(k), GMP, and problem reporting requirements.

A reengineering team comprised of FDA staff, industry and other non-government representatives have focused their efforts on a proposal with the following goals:

1. provide a process that will allow FDA to effectively regulate class III products from initial development to marketing to eventual replacement by more advanced products ,
2. reduce the FDA resources required to review and approve new class III devices ,
3. reduce the total time to get a new class III device to market , and 4) no reduction in the overall assurance of safety and effectiveness as compared with the PMA process. The process will be designed to facilitate use of expertise outside FDA and will provide a clear development path "road map" for products to the market.

Resources

A series of documents available on this web site provide current status information about the initiative. The documents are:

Guidance for Industry: Contents of a Product Development Protocol (updated 07/27/98 posted 2/05/99)
Summary Minutes of the October 22, 1997 HIMA/FDA PDP Public Worksho

Note: the document "PDP Comprehensive Outline with Attachments" has been replaced with the document "Contents of a Product Development Protocol" available at:

http://www.fda.gov/cdrh/pdp/420.html and
http://www.fda.gov/cdrh/pdp/pdpguide.pdf

Contacts

FDA is inviting interested parties to provide comments and suggestions to help in developing this alternative approach to the PMA process.

Your comments can either be sent in by email to PDPcomment@cdrh.fda.gov or can be addressed to:

PDP Reengineering Team
Center for Devices and Radiological Health (HFZ-150)
9200 Corporate Blvd
Rockville MD 20850

Back to Device Evaluation Page

Updated February 5, 1999

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