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