Current through October 31, 2024
Section 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 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. 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 85 FR 18443, 4/2/2020; 88 FR 16880, 3/21/2023