(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.