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

---
identifier: "/us/cfr/t21/s4.105"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 4.105 - What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?"
title_number: 21
title_name: "Food and Drugs"
section_number: "4.105"
section_name: "What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "4"
part_name: "REGULATION OF COMBINATION PRODUCTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 360l, 360hh-360ss, 360aaa-360bbb, 360ddd, 360ddd-1, 371(a), 372-374, 379e, 381, 383, 394; 42 U.S.C. 216, 262, 263a, 264, 271."
regulatory_source: "78 FR 4321, Jan. 22, 2013, unless otherwise noted."
cfr_part: "4"
---


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

(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.