CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 1]

[CITE: 21CFR1.1113]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A - GENERAL

PART 1 -- GENERAL ENFORCEMENT REGULATIONS

Subpart R - Laboratory Accreditation for Analyses of Foods

FDA Recognition of Accreditation Bodies

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

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.