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# PMA Critical to Quality Pilot Program
- URL: https://www.fdaweb.com/pma-critical-to-quality-pilot-program/
- Published: 2017-09-12T12:00:00.000Z
- Updated: 2026-09-14T22:48:40.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139607

*Federal Register* notice: FDA has announced a “Premarket Approval Application Critical to Quality” pilot program. Participation is voluntary and the program aims to evaluate device design and manufacturing process quality information early in the development process to assist FDA in its review of the PMA manufacturing section and post-approval inspections. It is part of FDA’s ongoing Case for Quality effort to apply innovative strategies that promote medical device quality. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-09-12/pdf/2017-19258.pdf?ref=fdaweb.com).