21 CFR § 822.16 Postmarket Surveillance

§ 822.16 What will you consider in the review of my submission?

Current through Sep 8, 2026 · Read all of Part 822

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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