---
kind: "section"
citation: "21 C.F.R. § 1.1130"
title: "21"
number: "1.1130"
heading: "How will FDA oversee recognized accreditation bodies?"
url: "https://uscodex.org/cfr/21/1.1130"
---

# §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.

## Notes

### Source

Source: 86 FR 68817, Dec. 3, 2021; 87 FR 5660, Feb. 2, 2022, unless otherwise noted.

### Authority

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 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.

### Source

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