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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.
42 FR 15553, Mar. 22, 1977, unless otherwise noted.
86 FR 68817, Dec. 3, 2021; 87 FR 5660, Feb. 2, 2022, unless otherwise noted.
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Subscribe to: 21 CFR Part 1 Subpart R - FDA Recognition of Accreditation Bodies
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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.
(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.
(a) Review of application for recognition or renewal of recognition. FDA will review an accreditation body's application for recognition or renewal of recognition for completeness and notify the applicant of any insufficiencies. FDA generally will review accreditation body applications for recognition or renewal of recognition in the order in which completed applications are received; however, FDA may prioritize the review of specific applications to meet program needs.
(b) Evaluation of application for recognition or renewal of recognition. FDA will evaluate a complete application for recognition or renewal of recognition to determine whether the applicant meets the requirements for recognition. Such evaluation may include an onsite evaluation of the accreditation body. If FDA does not reach a final decision on an application for renewal of recognition before an accreditation body's recognition expires, FDA may extend the existing term of recognition for a specified period of time or until FDA reaches a final decision on the application for renewal of recognition.
(c) Grant of recognition. FDA will notify the applicant that its application for recognition or renewal of recognition has been approved and will include any conditions associated with the recognition.
(d) Duration of recognition. FDA may grant recognition of an accreditation body for a period not to exceed 5 years from the date of recognition, except under the circumstances described in paragraph (b) of this section.
(e) Denial of application for recognition or renewal of recognition. FDA will notify the applicant that its application for recognition or renewal of recognition has been denied and will state the basis for such denial and describe the procedures for requesting reconsideration of the application under § 1.1171.
(f) Notice of records custodian after denial of an application for renewal of recognition. Within 10 business days of the date of FDA's issuance of a denial of an application for renewal of recognition, the applicant must provide the name and contact information of the custodian who will maintain required records and make them available to FDA under § 1.1124. The contact information must include an email address for the records custodian and the street address where the records required under § 1.1124 will be located.
(g) FDA notice to LAAF-accredited laboratories. FDA will promptly notify all laboratories LAAF-accredited by the accreditation body whose application for renewal of recognition was denied, informing them of such denial.
(h) Public notice of denial of an application for renewal of recognition of an accreditation body. FDA will provide public notice on the website described in § 1.1109 of the issuance of a denial of an application for renewal of recognition and will include the date of the issuance of such denial.
(a) Notice to FDA of intent to relinquish or not to renew recognition. At least 60 calendar days before voluntarily relinquishing its recognition or before allowing its recognition to expire without seeking renewal, a recognized accreditation body must notify FDA of its intention to leave the program, specifying the date on which the relinquishment or expiration will occur. The recognized accreditation body must provide the name and contact information of the custodian who will maintain and make available to FDA the records required by § 1.1124 after the date of relinquishment or the date recognition expires, as applicable. The contact information must include an email address for the records custodian and the street address where the records required under § 1.1124 will be located.
(b) Notice to LAAF-accredited laboratories of intent to relinquish or not to renew recognition. At least 60 calendar days before voluntarily relinquishing its recognition or before allowing its recognition to expire without seeking renewal, a recognized accreditation body must notify the laboratories it LAAF accredits of its intention to leave the program, specifying the date on which relinquishment or expiration will occur.
(c) Public notice of voluntary relinquishment or expiration of recognition. FDA will provide notice on the website described in § 1.1109 of the voluntary relinquishment or expiration of recognition of an accreditation body.
(a) Application following revocation of recognition. An accreditation body that has had its recognition revoked by FDA (as described in § 1.1131) may seek reinstatement by submitting a new application for recognition under § 1.1114. The accreditation body must also submit evidence to FDA with its application to demonstrate that the issues resulting in revocation of recognition have been resolved, including evidence addressing the cause or condition of the grounds for revocation of recognition. The evidence also must identify measures that have been implemented to help ensure that such cause or condition is unlikely to recur.