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Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies
February 19, 1998

See Related Info

General Program Guidance #P98-2 (FDAMA)

Director
Office of Device Evaluation (HFZ­400)

Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies

ODE Review Staff

Purpose

This guidance describes the procedures to be used to implement this interactive review provision. The guidance applies to original PMA applications received by FDA on or after February 19, 1998.

Guidance

The attached "Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry" was published on February 19, 1998. It sets forth the procedures for the request, preparation, documentation, and follow-up of "day-100" meetings.

Effective Date: February 19, 1998.




Susan Alpert, Ph.D., M.D.

PDF version of the Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry is also available. Information on Documents in Portable Document Format (pdf) is available.

 

Updated 6/30/1998

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