How will FDA evaluate applications for recognition and renewal of recognition?

21 C.F.R. § 1.1115
in effectEffective: 2024-07-01
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(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.

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