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

(h) 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.

(c) FDA will provide notice on the website described in § 1.1109 of the voluntary relinquishment or expiration of recognition of an accreditation body.

(2) The recognized accreditation body must notify FDA of the suspension under this section in accordance with the requirements of § 1.1123(d)(5). FDA will provide notice of the LAAF-accredited laboratory's suspension on the website described in § 1.1109.

(2) FDA will notify all laboratories LAAF-accredited by the recognized accreditation body that the recognized accreditation body is on probation and will provide notice of the probation on the website described in § 1.1109.

(a) 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 If the laboratory seeking LAAF-accreditation had its LAAF-accreditation withdrawn or one or more methods within its scope of LAAF-accreditation reduced by a recognized accreditation body or has been previously disqualified by FDA, the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) FDA will provide notice on the website described in § 1.1109 of the voluntary relinquishment of LAAF-accreditation of a laboratory.

(1) The LAAF-accredited laboratory must submit the results of all testing required to be conducted under this subpart directly to FDA via the location specified by the website described in § 1.1109, unless another location is specified by FDA regarding testing conducted under § 1.1107(a)(2) or (3).

(2) FDA will provide notice of a LAAF-accredited laboratory's probation on the website described in § 1.1109.