21 CFR § 1.1113 General Enforcement Regulations

§ 1.1113 What are the eligibility requirements for a recognized accreditation body?

Current through Sep 8, 2026 · Read all of Part 1

⚠ 1 pending change to Part 1

A recognized accreditation body or an accreditation body seeking recognition must meet all of the following requirements:

(a) Demonstrates compliance with ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101).

(b) Demonstrates that it is a full member of the International Laboratory Accreditation Cooperative (ILAC).

(c) Demonstrates that it is a signatory to the ILAC Mutual Recognition Arrangement (MRA) that has demonstrated competence to ISO/IEC 17011:2017(E) with a scope of “Testing: ISO/IEC 17025.”

(d) Will comply with all additional requirements for recognized accreditation bodies under this subpart while recognized.

← § 1.1110 What are the general requirements for submitting information to FDA under this subpart?§ 1.1114 How does an accreditation body apply to FDA for recognition or renewal of recognition? →