21 CFR 822.38 - What reports must I submit to you?

Regulations last checked for updates: May 02, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart G [§ 822.31 - § 822.38]

§ 822.38 - What reports must I submit to you?

You must submit interim and final reports as specified in your approved postmarket surveillance plan. In addition, we may ask you to submit additional information when we believe that the information is necessary for the protection of the public health and implementation of the act. We will also state the reason or purpose for the request and how we will use the information.

authority: 21 U.S.C. 331,352,360i,360l,371,374

source: 67 FR 38887, June 6, 2002, unless otherwise noted.

cite as: 21 CFR 822.38