GroundRules
21 CFR 820.7: Incorporation by reference.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 820—QUALITY MANAGEMENT SYSTEM REGULATION
- Subpart A—General Provisions
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON