21 C.F.R. § 820.7

Current through October 31, 2024

Section 820.7 - [Effective 2/2/2026] Incorporation by reference

Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51 . All approved incorporation by reference (IBR) material is available for inspection at the Food and Drug Administration, and at the National Archives and Records Administration (NARA). Contact FDA at: Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852; 240-402-7500; https://www.regulations.gov/document/FDA-2013-S-0610-0003. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email fr.inspection@nara.gov. This material may be obtained from the International Organization for Standardization (ISO), BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland; +41-22-749-01-11; customerservice@iso.org, https://www.iso.org/store.html.

(a) ISO 9000:2015(E) ("ISO 9000"), Quality Management systems-Fundamentals and vocabulary, Clause 3- Terms and definitions, Fourth edition, September 15, 2015. IBR approved for § 820.3 .

(b) ISO 13485:2016(E) ("ISO 13485"), Medical devices-Quality management systems-Requirements for regulatory purposes, Third edition, March 1, 2016; IBR approved for §§ 820.1 , 820.3 , 820.10 , 820.35 , and 820.45 .

21 C.F.R. §820.7

89 FR 7523 , 2/2/2026