21 CFR §4.105

1. (a)If you are a constituent part applicant:
   1. (1)You must maintain records in accordance with the recordkeeping requirements in the applicable regulation(s) described in § 4.102(b).
   2. (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).
2. (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.