{"data":{"id":"us/21-cfr-4.105","jurisdiction":"us","citation":"21 CFR 4.105","heading":"What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?","body":"(a) If you are a constituent part applicant:\n(1) You must maintain records in accordance with the recordkeeping requirements in the applicable regulation(s) described in § 4.102(b).\n(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).\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 4—REGULATION OF COMBINATION PRODUCTS","Subpart B—Postmarketing Safety Reporting for Combination Products"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"62076454d8ba2c26715aca13902f1d61cdeaaace4e34f90162bf68c6efff1d2b","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-4.104","next":"us/21-cfr-5.1100"},"notice":"GroundRules: Original legal text. Not legal advice."}