21 CFR 814.2
§ 814.2 Purpose.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 814.2, § 814.2 Purpose, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88852
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Full text
The purpose of this part is to establish an efficient and thorough device review process—
(a) To facilitate the approval of PMA's for devices that have been shown to be safe and effective and that otherwise meet the statutory criteria for approval; and
(b) To ensure the disapproval of PMA's for devices that have not been shown to be safe and effective or that do not otherwise meet the statutory criteria for approval. This part shall be construed in light of these objectives.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.