---
kind: "section"
citation: "21 C.F.R. § 820.7"
title: "21"
number: "820.7"
heading: "Incorporation by reference."
url: "https://uscodex.org/cfr/21/820.7"
---

# §820.7. 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)](/usc/5/552.md?p=a) and [1](/usc/5/1.md) CFR [part 51](/cfr/21/part51.md). 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](/cfr/21/820.3.md).
- (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](/cfr/21/820.1.md), [820.3](/cfr/21/820.3.md), [820.10](/cfr/21/820.10.md), [820.35](/cfr/21/820.35.md), and [820.45](/cfr/21/820.45.md).

## Notes

### Authority

Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

### Source

Source: 89 FR 7523, Feb. 2, 2024, unless otherwise noted.