21 CFR Part 814 · Premarket Approval of Medical Devices

§ 814.122 Confidentiality of data and information

Subpart H - Humanitarian Use Devices Official text on eCFR Amendment history

(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 , 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 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) , as applicable.

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FDA guidance that cites § 814.122

Procedures for Meetings of the Medical Devices Advisory Committee: Guidance for Industry and Food and Drug Administration Staff 1 Sept 2017

Amendment history

Federal Register documents that created or amended this section.

51 FR 26364 22 Jul 1986