what is the difference between iso 13485 and 21 cfr 820?

Various countries worked in collaboration with other members of ISO to create ISO 13485.Ģ1 CFR Part 820 was created solely by the FDA. The structure remains unchanged since 1997. commercial distribution of medical devices. 21 CFR Part 820 is regulation and mandatory for U.S. Other countries may have their own regulations. Prioritizes a risk-based approach and cites related standards such as ISO 14971 for managing medical device product risk management.įDA Part 820 rarely specifies requirements for risk management. Mandated regulation USA medical device manufacturers- when a requirement is met as per FDA 21 CFR Part 820, it is known as compliance. Voluntary standard – when a requirement is met as per ISO 13485, it is known as conformance. The below comparison matrix will help you understand the working scopes, applications, and domains of both the standard and the regulation. ISO 13485 and FDA 21 CFR Part 820 are compared based on their purposes, histories, scopes, and influences on each other.

Comparing ISO 13485 with FDA 21 CFR Part 820 With compliance with the subject regulation, companies can market medical devices in the U.S.A commercially as well as internationally. Organizations conforming to 21 CFR Part 820 can move confidently towards compliance with ISO 13485:2016. There are significant similarities between 21 CFR Part 820 and ISO 13485:2016, but there are still a few minor specifications that might not be explicitly contained within ISO 13485. 21 CFR Part 820, Medical Devices – Quality System Regulation, is a mandatory FDA regulation that medical device manufacturers and suppliers must comply with to distribute devices in the U.S. ISO 13485:2016, Medical devices – Quality Management Systems, is a voluntary standard for medical device manufacturers and suppliers and is used worldwide for developing and maintaining the system that caters to the needs of the market requirements for medical devices. Overlapping Regulations for Medical Device Manufacturing Since international medical device regulators (including the ones in EU, Canada, Australia, and Japan) stand their quality system requirements on ISO 13485:2016, the FDA can renew the regulation to align with a wider, universally trusted quality system standard. As medical device companies increasingly distribute globally, they have had to comply with both requirements, as well as other international requirements. The intent is to coalesce 21 CFR Part 820 with ISO 13485:2016 to harmonize requirements while revamping the regulation, which hasn’t been updated in more than 20 years. The FDA is presently working on transitioning its QSR requirements to ISO 13485.

What is the difference between iso 13485 and 21 cfr 820?