What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?

§ 4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part? (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.