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?

(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).