GroundRules
21 CFR 4.105: What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?
Where this section sits in the code
- 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
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON