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30-Day Notices and 135-Day PMA Supplements for Manufacturing
Method or Process Changes
February 19, 1998
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General Program Guidance P98-4 (FDAMA)

 

Director
Office of Device Evaluation (HFZ­400)

30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes

ODE Review Staff

Purpose

The purpose of this guidance is to describe what changes generally will qualify for the 30-day Notice and what changes generally will not. For those changes in manufacturing that generally will not qualify for 30-day Notices, FDA requests PMA holders to submit supplemental PMAs or consult the agency on a case-by-case basis.

Guidance

The attached "30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH" was published on February 19, 1998. It discusses the qualifying changes for the submission, contents and review procedures of 30-day and 135-day PMA supplements.

Effective Date: February 19, 1998.




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

PDF version of the 30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH is also available. Information on Documents in Portable Document Format (pdf) is available.

Updated 6/30/1998

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