21 CFR § 1.1139 - How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?

---
identifier: "/us/cfr/t21/s1.1139"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1.1139 - How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?"
title_number: 21
title_name: "Food and Drugs"
section_number: "1.1139"
section_name: "How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "1"
part_name: "GENERAL ENFORCEMENT REGULATIONS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271."
regulatory_source: "42 FR 15553, Mar. 22, 1977, unless otherwise noted."
cfr_part: "1"
---


# 1.1139 How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?

(a) *Application for LAAF-accreditation.* A laboratory seeking LAAF-accreditation or extension of its scope of LAAF-accreditation must submit its application for LAAF-accreditation to a recognized accreditation body identified on the website described in § 1.1109. The recognized accreditation body will review and assess the application in accordance with the requirements of this subpart. If the laboratory seeking LAAF-accreditation had its LAAF-accreditation withdrawn or one or more methods within its scope of LAAF-accreditation reduced by a recognized accreditation body or has been previously disqualified by FDA, the laboratory must meet the additional requirements specified by § 1.1142(a).

(b) *Documentation of conformance with ISO/IEC 17025:2017(E).* The laboratory may use documentation of conformance with ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101), as applicable and supplemented as necessary, in meeting the applicable requirements of this subpart.

(c) *Duration of accreditation.* If a LAAF-accredited laboratory maintains compliance with all requirements of this subpart, including accreditation to ISO/IEC 17025:2017(E), the laboratory's LAAF-accreditation will not end until reduced in scope, withdrawn, relinquished, or the laboratory is disqualified, under this subpart.