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

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If you are a constituent part applicant:

You must maintain records in accordance with the recordkeeping requirements in the applicable regulation(s) described in § 4.102(b).

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).

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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§ 4.104 - How and where must you submit postmarketing safety reports for your combination product or constituent part?
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