---
kind: "section"
citation: "21 C.F.R. § 814.122"
title: "21"
number: "814.122"
heading: "Confidentiality of data and information."
url: "https://uscodex.org/cfr/21/814.122"
---

# §814.122. Confidentiality of data and information.

- (a) **Requirement for disclosure.** The “HDE file” includes all data and information submitted with or referenced in the HDE, any IDE incorporated into the HDE, any HDE amendment or supplement, any report submitted under [§ 814.126](/cfr/21/814.126.md), any master file, or any other related submission. Any record in the HDE file will be available for public disclosure in accordance with the provisions of this section and [part 20](/cfr/21/part20.md) of this chapter.
- (b) **Extent of disclosure.** Disclosure by FDA of the existence and contents of an HDE file shall be subject to the same rules that pertain to PMA's under [§ 814.9(b) through (h)](/cfr/21/814.9.md?p=b..h), as applicable.

## Notes

### Source

Source: 61 FR 33244, June 26, 1996, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.

### Source

Source: 51 FR 26364, July 22, 1986, unless otherwise noted.