21 C.F.R. § 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.