(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.).
[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]