§1.1139. How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?
21 C.F.R. § 1.1139
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 If the laboratory seeking LAAF-accreditation had its LAAF-accreditation withdrawn or one or more methods within its scope of LAAF-accreditation reduced by a recognized accreditation body or has been previously disqualified by FDA, the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).
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.
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accreditation to ISO/IEC 17025:2017(E), the laboratory's LAAF-accreditation will not end until reduced in scope, withdrawn, relinquished, or the laboratory is disqualified, under this subpart.
Notes, amendments, and revision history
Source
Source: 86 FR 68817, Dec. 3, 2021; 87 FR 5660, Feb. 2, 2022, unless otherwise noted.
Authority
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.
Source
Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.