(a) If you disagree with us about the content of your plan or if we disapprove your plan, or if you believe there is a less burdensome approach that will answer the surveillance question, you may request review of our decision by:
- (1) Requesting a meeting with the individual who 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.
[67 FR 38887, June 6, 2002, as amended at 72 FR 17400, Apr. 9, 2007; 85 FR 18443, Apr. 2, 2020]