Home » Compare ISO 9001 and FDA-QSR-21CFR-820

Compare ISO 13485 and FDA-QSR-21CFR-820

Also see: What is ISO 13485?

What is 21 CFR 820?

• Title 21 of the Code of Federal Regulations (CFR) covers the broad area of food and drugs
• Part 820 outlines
  • Quality Systems for medical device manufacturers.
  • Current Good Manufacturing Practice (CGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.
  • These requirements are meant to ensure that medical devices are safe, effective, and in
    compliance with the Federal Food, Drug, and Cosmetic Act.

Where do they each apply?

• ISO 13485 is a global standard that is voluntary in the US but required in some countries. Third party registrars (CB's) conduct audits to ensure conformance.
  • The Food and Drug Administration enforces 21 CFR 820.
• 21 CFR 820 is applicable to manufacturers of finished medical devices sold in the United States,
  including imported products. Only parts of the requirement may apply, depending on the class.
  • See Medial Device Terminology & Classifications

Relationship between FDA-QSR 21 CFR 820 and ISO 13485?

They have several differences, which is what have kept them from harmonizing.

• The FDA QSR has more stringent complaint handling & reporting requirements

Comparison Matrix of ISO 13485 and FDA QSR 820

US FDA Medical Device Regulations & Guidelines

• Design Control Guidance for Medical Device Manufacturers
  Text related to FDA 21 CFR 820.30 and sub clause 4.4 of ISO 9001.
• Labeling for Medical Devices
  Guidance on medical device labeling from the FDA
• Quality Systems Regulations (QSR)
  US FDA QSR regulation and Good Manufacturing Practices (GMP).
• Post Market Surveillance
  Guidance on criteria and approaches for medical device post-market surveillance.
• Human Factors in Medical Device Design
  Discusses the CDRH push to have manufacturers apply Human Factors to device design.