21 CFR Part 4 · Regulation of Combination Products

§ 4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?

Subpart B - Postmarketing Safety Reporting for Combination Products Official text on eCFR Amendment history

(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 .

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

FDA guidance that cites § 4.105

Amendment history

Federal Register documents that created or amended this section.