21 CFR § 822.37 Postmarket Surveillance

§ 822.37 Under what circumstances would you inspect records identifying subjects?

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

We can inspect and copy records identifying subjects under the same circumstances that we can inspect any records relating to postmarket surveillance. We are likely to be interested in such records if we have reason to believe that required reports have not been submitted, or are incomplete, inaccurate, false, or misleading.

← § 822.36 Can you inspect and copy the records related to my postmarket surveillance plan?§ 822.38 What reports must I submit to you? →