21 CFR Part 822 · Postmarket Surveillance

§ 822.7 What should I do if I do not agree that postmarket surveillance is appropriate?

Subpart B - Notification Official text on eCFR Amendment history

(a) If you do not agree with our decision to order postmarket surveillance for a particular device, you may request review of our decision by:

(1) Requesting a meeting with the Director of the Office that issued the order for postmarket surveillance;

(2) Seeking internal review of the order under § 10.75 of this chapter ;

(3) Requesting an informal hearing under part 16 of this chapter ; or

(4) Requesting review by the Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee.

(b) You may obtain guidance documents that discuss these mechanisms from the Center for Devices and Radiological Health's (CDRH's) Web site ( http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOmbudsman/default.htm . ).

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 § 822.7

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
72 FR 17399 9 Apr 2007
78 FR 18233 26 Mar 2013
85 FR 18843 2 Apr 2020
88 FR 16880 21 Mar 2023