---
kind: "section"
citation: "21 C.F.R. § 4.105"
title: "21"
number: "4.105"
heading: "What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?"
url: "https://uscodex.org/cfr/21/4.105"
---

# §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)](/cfr/21/4.102.md?p=b).
  - (2) You must maintain records required under [§ 4.103(b)](/cfr/21/4.103.md?p=b) for the longest time period required for records under the postmarketing safety reporting regulations applicable to your product under [§ 4.102(b)](/cfr/21/4.102.md?p=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](/cfr/21/4.102.md).

## Notes

### Source

Source: 81 FR 92624, Dec. 20, 2016, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 360l, 360hh-360ss, 360aaa-360bbb, 360ddd, 360ddd-1, 371(a), 372-374, 379e, 381, 383, 394; 42 U.S.C. 216, 262, 263a, 264, 271.

### Source

Source: 78 FR 4321, Jan. 22, 2013, unless otherwise noted.