21 CFR 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, 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.
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.