§ 4.105. What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?
89 words·~1 min read·
/us/cfr/t21/s§ 4.105·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.
Connections4 cite this
Cited by 4 sections
Citation graph
cites case law
§ 4.105
What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?
Fed. Reg.×4
Cites 0Cited by 4 across 1 source