§ 822.38 What reports must I submit to you?

You must submit interim and final reports as specified in your approved postmarket surveillance plan. In addition, we may ask you to submit additional information when we believe that the information is necessary for the protection of the public health and implementation of the act. We will also state the reason or purpose for the request and how we will use the information.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

FDA guidance that cites § 822.38

• Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff 7 Oct 2022

Amendment history

Federal Register documents that created or amended this section.

• 67 FR 38887 6 Jun 2002
• 78 FR 58823 24 Sept 2013
• 78 FR 58825 24 Sept 2013