§ 1.1130 - How will FDA oversee recognized accreditation bodies?

§ 1.1130 How will FDA oversee recognized accreditation bodies?

(a) FDA will evaluate each recognized accreditation body to determine its compliance with the applicable requirements of this subpart no later than:

(1) Year 4 of a 5-year recognition period; or

(2) The midpoint of a recognition period less than 5 years.

(b) An FDA evaluation of a recognized accreditation body may include review of records, an onsite evaluation of the accreditation body, and onsite reviews of one or more LAAF-accredited laboratories the recognized accreditation body LAAF-accredits, with or without the recognized accreditation body present. Certain evaluation activities may be conducted remotely if it will not aid in the evaluation to conduct them onsite.

(c) FDA may conduct additional evaluations of a recognized accreditation body at any time to determine whether the recognized accreditation body complies with the applicable requirements of this subpart.