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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER H: MEDICAL DEVICES
PART 822: POSTMARKET SURVEILLANCE
Subpart D: FDA Review and Action
822.22 - What recourse do I have if I do not agree with your decision
(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 Director, Office of Surveillance and Biometrics, Center for Devices and Radiological Health (CDRH), who generally issues 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]
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