Current through May 31, 2024
Section 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 .