Edition 2026-11 · Free sample page · 04-regulatory-map/jurisdictions/united-states.md

United States

United States: regulator, QMS basis, market-access route and primary instruments with official links.

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About this page

Type: Reference page
Source: Written for the pack
Edition: Edition 2026-11
Primary source: www.fda.gov
Sources: U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH)
Tags: regulatory-map, united-states
Status: Stable
Licence: Individual licence, Edition 2026-11; see LICENSE.md

Front matter, as shipped

---
type: "reference"
title: "United States"
description: "United States: regulator, QMS basis, market-access route and primary instruments with official links."
source: "authored"
date: "2026-11"
edition: "2026-11"
licence: "Individual licence, Edition 2026-11; see LICENSE.md"
resource: "https://www.fda.gov/medical-devices"
sources:
  - {id: "regulator", resource: "https://www.fda.gov/medical-devices", title: "U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH)"}
tags: ["regulatory-map", "united-states"]
status: "stable"
---

Free sample of the QMSR Knowledge Pack, Edition 2026-11, published here by Koala Tea with Neel LLC. Reading this page needs no licence; the download and the full pack are licensed per person.

Regulator	U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH)
QMS basis	21 CFR Part 820, the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference and adds FDA-specific requirements in 820.10, 820.35 and 820.45. Effective 2 February 2026.
Market access	Premarket notification (510(k)), De Novo classification request or premarket approval (PMA) depending on device class; class I and some class II devices are exempt from premarket notification but not from the QMSR unless exempted by regulation. Establishment registration and device listing under 21 CFR Part 807 are annual.

Primary instruments

Instrument	Official link
Federal Food, Drug, and Cosmetic Act, chapter V (devices)	www.fda.gov
21 CFR Part 820, Quality Management System Regulation	www.ecfr.gov
Final rule: Medical Devices; Quality System Regulation Amendments, 89 FR 7496 (2 February 2024)	www.federalregister.gov
21 CFR Part 803, Medical Device Reporting	www.ecfr.gov
21 CFR Part 806, Medical Devices; Reports of Corrections and Removals	www.ecfr.gov
21 CFR Part 807, Establishment Registration and Device Listing	www.ecfr.gov
21 CFR Part 821, Medical Device Tracking Requirements	www.ecfr.gov
21 CFR Part 830, Unique Device Identification	www.ecfr.gov
21 CFR Part 11, Electronic Records; Electronic Signatures	www.ecfr.gov
Compliance Program 7382.850, Inspection of Medical Device Manufacturers (current edition, implementation date 2 February 2026; PDF)	www.fda.gov
FDA Compliance Program Manual (index of all compliance programs, including CP 7382.850)	www.fda.gov

Notes

FDA inspections of device manufacturers follow Compliance Program 7382.850 (see section 02 of this pack). The eCFR links above always show the text in force; the Federal Register link is the rule as published.
FDA uses MDSAP audit reports as a substitute for its surveillance inspections at sites that volunteer for the program and does not conduct surveillance inspections at sites actively enrolled; every manufacturer remains subject to the five non-surveillance inspections (compliance follow-up, for-cause, Specific Product Risk Assignment (SPRA), PMA preapproval and PMA postmarket) and to inspection of electronic product radiation control activities.
Section 524B of the FD&C Act adds cybersecurity requirements for 'cyber devices' in premarket submissions.

Links checked 13 October 2026.

QMSR Knowledge Pack, Edition 2026-11. Professional reference material, not legal or regulatory advice. Licensed per person; see LICENSE.md.

Who wrote it

Written by Neelank Tiwari, MS, PMP, DEKRA ISO 13485 Lead Auditor, ASQ CMQ-OE, CQA, CMDA, CSQP, CQIA.

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Free sample of the QMSR Knowledge Pack, Edition 2026-11, published here by Koala Tea with Neel LLC. Reading this page needs no licence; the download and the full pack are licensed per person. Seller: Koala Tea with Neel LLC; questions to tiwarineelank@gmail.com.