---
kind: "section"
citation: "21 C.F.R. § 4.103"
title: "21"
number: "4.103"
heading: "What information must you share with other constituent part applicants for the combination product?"
url: "https://uscodex.org/cfr/21/4.103"
---

# §4.103. What information must you share with other constituent part applicants for the combination product?

- (a) When you receive information regarding an event that involves a death or serious injury as described in [§ 803.3](/cfr/21/803.3.md) of this chapter, or an adverse experience as described in [§ 314.80(a)](/cfr/21/314.80.md?p=a) of this chapter or [§ 600.80(a)](/cfr/21/600.80.md?p=a) of this chapter, associated with the use of the combination product, you must provide the information to the other constituent part applicant(s) for the combination product no later than 5 calendar days of your receipt of the information.
- (b) With regard to information you must provide to the other constituent part applicant(s) for the combination product, you must maintain records that include:
  - (1) A copy of the information you provided,
  - (2) The date the information was received by you,
  - (3) The date the information was provided to the other constituent part applicant(s), and
  - (4) **The name and address of the other constituent part applicant(s) to whom you provided the information.**

## 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.