{"data":{"id":"us/21-cfr-4.104","jurisdiction":"us","citation":"21 CFR 4.104","heading":"How and where must you submit postmarketing safety reports for your combination product or constituent part?","body":"(a) If you are a constituent part applicant, you must submit postmarketing safety reports in accordance with the regulations identified in § 4.102(b) that are applicable to your product based on its application type.\n(b) If you are a combination product applicant, you must submit postmarketing safety reports required under § 4.102 in the manner specified in the regulation applicable to the type of report, with the following exceptions:\n(1) You must submit the postmarketing safety reports identified in § 4.102(c)(1)(i) and (ii) in accordance with § 314.80(g) of this chapter if your combination product received marketing authorization under an NDA or ANDA or in accordance with § 600.80(h) of this chapter if your combination product received marketing authorization under a BLA.\n(2) You must submit the postmarketing safety reports identified in § 4.102(c)(2)(ii) and (c)(3)(ii) in accordance with § 803.12(a) of this chapter if your combination product received marketing authorization under a device application.","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":"ad580bc534c37814f8bd3bd35a77d95c31faff9bc16bd4a050b8fd4b7651b66d","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-4.103","next":"us/21-cfr-4.105"},"notice":"GroundRules: Original legal text. Not legal advice."}