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Code · CFR · Title 21 — Food and Drugs · Part 822 — Postmarket Surveillance · § 822.16

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

51 words·~1 min read·/us/cfr/t21/s§ 822.16·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

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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