21 CFR 822.16 - What will you consider in the review of my submission?

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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

822.16 - What will you consider in the review of my submission

First, we will determine that the submission is administratively complete. Then, in accordance with the law, we must determine whether the designated person has appropriate qualifications and experience to conduct the surveillance and whether the surveillance plan will result in the collection of useful data that will answer the surveillance question.

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