---
kind: "section"
citation: "21 C.F.R. § 822.7"
title: "21"
number: "822.7"
heading: "What should I do if I do not agree that postmarket surveillance is appropriate?"
url: "https://uscodex.org/cfr/21/822.7"
---

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

- (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](/cfr/21/10.75.md) of this chapter;
  - (3) Requesting an informal hearing under [part 16](/cfr/21/part16.md) 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.).

## Notes

### Amendments

[67 FR 38887, June 6, 2002, as amended at 72 FR 17399, Apr. 9, 2007; 78 FR 18233, Mar. 26, 2013; 85 FR 18843, Apr. 2, 2020; 88 FR 16880, Mar. 21, 2023]

### Authority

Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.

### Source

Source: 67 FR 38887, June 6, 2002, unless otherwise noted.

### Amendments

[67 FR 38887, June 6, 2002, as amended at 72 FR 17399, Apr. 9, 2007; 78 FR 18233, Mar. 26, 2013; 85 FR 18843, Apr. 2, 2020; 88 FR 16880, Mar. 21, 2023]