21 CFR 822.14 - May I reference information previously submitted instead of submitting it again?

Regulations last checked for updates: Mar 13, 2025

Title 21 - Food and Drugs last revised: Feb 25, 2025

View all text of Subpart C [§ 822.8 - § 822.15]

§ 822.14 - May I reference information previously submitted instead of submitting it again?

Yes, you may reference information that you have submitted in premarket submissions as well as other postmarket surveillance submissions. You must specify the information to be incorporated and the document number and pages where the information is located.

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 822.14