Current as of October 03, 2022 | Updated by FindLaw Staff
Welcome to FindLaw's Cases & Codes, a free source of state and federal court opinions, state laws, and the United States Code. For more information about the legal concepts addressed by these cases and statutes, visit FindLaw's Learn About the Law.
(a) If you are a constituent part applicant:
(1) You must maintain records in accordance with the recordkeeping requirements in the applicable regulation(s) described in § 4.102(b).
(2) You must maintain records required under § 4.103(b) for the longest time period required for records under the postmarketing safety reporting regulations applicable to your product under § 4.102(b).
(b) If you are a combination product applicant, you must maintain records in accordance with the longest time period required for records under the regulations applicable to your product under § 4.102.
Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part? - last updated October 03, 2022 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-4-105.html
FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature or via Westlaw before relying on it for your legal needs.
Was this helpful?