Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 1 / 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 / § 4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?
§ 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.