21 CFR 1.1114
§ 1.1114 How does an accreditation body apply to FDA for recognition or renewal of recognition?
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 1.1114, § 1.1114 How does an accreditation body apply to FDA for recognition or renewal of recognition?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/82910
- Permanent ID
ys:prov:82910@1- SHA-256
1757ccde87db1d0d9134afe833b47d7678033a537802ccfe9602e9b9e10eb367
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
(a) Application for recognition or renewal of recognition. An accreditation body seeking initial recognition or renewal of recognition must submit an application to FDA demonstrating that it meets the eligibility requirements in § 1.1113.
(b) Documentation of conformance with requirements. The accreditation body must submit documentation of conformance with ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101) and separate documentation of ILAC membership and ILAC MRA signatory status demonstrating competence to ISO/IEC 17011:2017(E) with a scope of “Testing: ISO/IEC 17025,” in meeting the requirements of § 1.1113(a) through (c). The accreditation body also must submit documentation of its compliance with § 1.1113(d).
(c) Signature. An application for recognition or renewal of recognition must be signed in the manner designated by FDA by an individual authorized to act on behalf of the applicant for purposes of seeking recognition or renewal of recognition.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.