21 C.F.R. § 822.16 What will you consider in the review of my submission?
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 822—POSTMARKET SURVEILLANCE
Subpart D—FDA Review and Action
§ 822.16 What will you consider in the review of my submission?
