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

Also see: What is ISO 13485? & View ISO 13485 to FDA QSR 820 Products

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.

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

They have several differences, which is what have kept them from harmonizing. ISO 13485:2003 is a standard based on ISO 9001 that is specific to medical devices. This standard is not adopted by the Food and Drug Administration (FDA) but the FDA participated in writing ISO 13485:2003 to make sure their requirements and ISO 13485:2003 are aligned. The FDA QSR has more stringent complaint handling & reporting requirements

However, if a company meets the requirements of ISO 13485:2003, they should easily be able to meet the FDA Quality System Requirements (QSR).

PDFComparison Matrix of ISO 13485 and FDA QSR 820

Need help migrating from ISO 13485 to FDA QSR 820?

US FDA Medical Device Regulations & Guidelines