Barry-Wehmiller Network

Medical Device Quality System Regulations: Transitioning from 21 CFR Part 820 to ISO 13485

 February 05, 2020

The U.S. Food and Drug Administration (FDA) has announced their intention to transition from 21 CFR Part 820 to ISO 13485. 

What does this mean for you and your organization with regards to ensuring quality and fulfilling your regulatory compliance obligations?

According to the FDA’s Center for Devices and Radiological Health (CDRH), there is approximately a 95% overlap between 21 CFR Part 820 and ISO 13485.  The good news is that companies who comply with the current 21 CFR Part 820 regulations are mostly in line with the new direction the FDA is going. 

However, there are additional regulations which are not covered in 21 CFR Part 820, which can be addressed by performing a thorough gap assessment to identify opportunities for compliance remediation.

Some benefits of this change include:

  • Reduced Cost of Compliance

With the shift to the ISO 13485, the number of standards companies have to follow are reduced allowing a greater focus on the smaller quantity of regulations.

  • Consistent Standard for International Product Market

21 CFR Part 820 is only applicable to products manufactured for sale in the United States.By shifting to ISO 13485, the United States is joining many other countries, reducing the burden on companies who seek to market internationally.

  • Potentially Reducing the Number of Audits

The FDA is planning to lean heavily into the Medical Device Single Audit Program (MDSAP) as the MDSAP follows ISO 13485.MDSAP harmonization may reduce the burden of multiple audits impacting day to day operations.

Design Group’s Regulatory Compliance team has experience across the nation and across industries in designing, auditing, and remediating Quality Management Systems to both standards, and can assist you and your company smoothly transition with the FDA. Connect with our consultants to learn more.

Blog CTA Medical Devices

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About the author

Joseph Olewinski


Joseph Olewinski is a Quality Engineer at Design Group. He has a BS in Biomedical Engineering.

His responsibilities include ensuring regulatory requirements are met for cGMP documentation and quality systems, supporting regulatory and compliance activities, performing data integrity assessments, and remediation of regulatory non-compliances.