MyRHC Compliance index

FDA

FDA Quality Management System Regulation (21 CFR Part 820)

FDA's Quality Management System Regulation for medical device manufacturers, effective 2026-02-02, incorporating ISO 13485:2016 by reference.

Medical Device Biotech & Life Sciences Healthcare US

At a glance

Short name
FDA QMSR
Issuing / stewarding body
FDA
Jurisdiction
US
Also known as / related labels
FDA QMSR · ISO 13485:2016 · ISO 9000:2015 clause 3 · cGMP

What this entry covers

21 CFR Part 820 sets the current good manufacturing practice (CGMP) quality management system requirements for the design, manufacture, packaging, labeling, storage, installation and servicing of finished devices intended for human use. Since 2026-02-02 it is titled the Quality Management System Regulation (QMSR) and incorporates ISO 13485:2016, and clause 3 of ISO 9000:2015 for terms and definitions, by reference.

MyRHC indexes this framework so practitioners, auditors, and automated agents can find the authoritative primary sources in one place. This page is a navigation aid; it is not legal advice and is not a substitute for the official text.

Official documentation

Recent changes

  • 2026-02-02: The amended Part 820, now titled the Quality Management System Regulation (QMSR), took effect. It incorporates ISO 13485:2016 and clause 3 of ISO 9000:2015 by reference, and FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections. FDA

How to use this index entry

  1. Open the official link above (or the agency home if the deep link drifts).
  2. Confirm edition / revision date against your program scope.
  3. Map applicability by sector and jurisdiction listed in the metadata.
  4. Follow related frameworks only after checking their own official sources.

Disclaimers

  • MyRHC does not host proprietary standards text (ISO, some industry bodies).
  • Where standards are paywalled, we link to the publisher’s catalog page.
  • Always verify current requirements with counsel and the issuing authority.
Index only — not legal advice. MyRHC does not certify compliance. Confirm current requirements with the issuing authority and qualified counsel. Proprietary standards text remains with its publisher.

Same agencies or sectors — still verify each official source independently.

CLIA

Official

Clinical Laboratory Improvement Amendments (CLIA)

Federal quality standards for US laboratories testing human specimens, administered by CMS with CDC and FDA under 42 CFR Part 493.

CMS CDC Clinical Research Healthcare

Common Rule

Official

Common Rule (45 CFR Part 46) and IRB Oversight

HHS regulations at 45 CFR Part 46 protecting human research subjects and governing IRB review, overseen by the Office for Human Research Protections.

HHS OHRP Clinical Research Biotech & Life Sciences

CGMP

Official

Current Good Manufacturing Practice (CGMP) for Drugs

FDA current good manufacturing practice regulations for drug manufacturing, processing, packing and holding (21 CFR Parts 210 and 211).

FDA Healthcare Biotech & Life Sciences

Data Retention

Official

Data Retention and Secure Destruction

Index of US federal sources on records retention and media sanitization, including HIPAA documentation rules, 21 CFR Part 11 and NIST SP 800-88.

HHS FDA Data Management Healthcare

DSCSA

Official

Drug Supply Chain Security Act (DSCSA)

US law setting up electronic, interoperable tracing of prescription drug packages through the supply chain, implemented by the FDA.

FDA Supply Chain Pharma

FDA Part 11

Official

FDA 21 CFR Part 11: Electronic Records and Electronic Signatures

FDA regulation, 21 CFR Part 11, setting criteria under which electronic records and electronic signatures are accepted in place of paper records.

FDA Healthcare Biotech & Life Sciences