21 CFR 4.105
§ 4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 4.105, § 4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83016
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.