FDA Proposal to Align US Quality System Regulations with ISO 13485

The U.S. Food and Drug Administration (FDA) has proposed to align the US medical device quality system regulation (21 CFR Part 820), with ISO 13485 - Medical Devices - Quality Management Systems (QMS) - Requirements for Regulatory Purposes. 

Medical device companies are required to establish and maintain a quality system to ensure their product(s) consistently meet applicable requirements. This is achieved through Title 21 of the Code of Federal Regulations, Part 820, which provides current good manufacturing practice (CGMP) requirements for establishing a quality system. The FDA is now seeking to harmonise these requirements with ISO 13485:2016 requirements used by many other regulatory authorities around the world. 

FDA believes there are a number of reasons which justify the change. These include:

• Regulatory expectations for quality management systems have evolved since the QS regulation was implemented over 20 years ago; 
• ISO 13485:2016 is widely used by many other countries;
• Lessons learnt through current and previous FDA programs which already utilise ISO 13485 demonstrate the feasibility and benefits of incorporating it;
• The requirements of 21 CFR Part 820 are already substantially similar to those in ISO 13485:2016. 

The goal of the proposal is to reduce the burden on medical device manufacturers with global products that face differing international regulations. The proposal would bring US QMS requirements closer in line with quality system requirements in markets such as the European Union, Japan and Australia, potentially streamlining medical device registration and compliance processes across the US and other markets. It would also keep country-specific requirements to a minimum and ensure that a similar level of assurance in a manufacturer’s QMS is maintained.

24 February 2022