21 CFR 814.114

§ 814.114 Timeframes for reviewing an HDE.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 814.114, § 814.114 Timeframes for reviewing an HDE, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88883
Permanent ID: ys:prov:88883@1
SHA-256: aec5f41e06e26333a6135532d3794edc4ba7d8e5817d66311f2aca8b681ab865

The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.

Full text

Within 75 days after receipt of an HDE that is accepted for filing and to which the applicant does not submit a major amendment, FDA shall send the applicant an approval order, an approvable letter, a not approvable letter (under § 814.116), or an order denying approval (under § 814.118).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.