21 CFR 1.1109 - How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?

Regulations last checked for updates: May 16, 2024

Title 21 - Food and Drugs last revised: May 06, 2024

View all text of Subpart R [§ 1.1101 - § 1.1200]

§ 1.1109 - How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?

FDA will place on its website a publicly available registry listing of:

(a) Recognized accreditation bodies, including for each: the name, contact information, and duration of recognition of the recognized accreditation body;

(b) Accreditation bodies that have a change in recognition, including for each: the name of the accreditation body, the specific change in recognition (i.e., probation, revocation of recognition, denial of renewal of recognition, relinquishment of recognition, or expiration of recognition) and the effective date of the change;

(c) LAAF-accredited laboratories, including for each: the name, contact information, and scope of LAAF-accreditation, and the name and contact information of the recognized accreditation body that has LAAF-accredited the laboratory; and

(d) Laboratories that have a change in LAAF-accreditation, including for each: the name of the laboratory, the specific change in LAAF-accreditation (i.e., suspension, reduction of scope, or withdrawal of LAAF-accreditation by the recognized accreditation body, probation or disqualification by FDA, or relinquishment of LAAF-accreditation), and the effective date of the change.

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; 42 U.S.C. 216,241,243,262,264,271

source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

cite as: 21 CFR 1.1109