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# Guide on Device Post-approval Studies
- URL: https://www.fdaweb.com/guide-on-device-post-approval-studies/
- Published: 2021-05-27T12:00:00.000Z
- Updated: 2026-09-14T17:00:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149415

*Federal Register* notice: FDA has made available a draft guidance entitled *Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order*. The document updates a 2009 guidance to assist stakeholders with understanding post-approval study requirements imposed as a PMA approval condition. To view the notice, click here.