part_subject: "REGULATION OF COMBINATION PRODUCTS"
subpart_code: "B"
subpart_subject: "Postmarketing Safety Reporting for Combination Products"
section_number: "4.105"
section_subject: "What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?"
cfr_reference: "21 CFR 4.105"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 1 to 99"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
(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.