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e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter APart 4Subpart B → §4.105


Title 21: Food and Drugs
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?

(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.

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