Will 21CFR820 be fully replaced by ISO 13485?

On January 31st 2024 FDA published the final rule to amend 21 CFR 820, the FDA Quality System Regulation (QS Reg) to incorporate, by reference ISO13485:2016. The final decision was presented four years after FDA announced their intention to perform a revision of the regulation, the first one since 1996.

Course description:

In this webinar, you will learn about the scope and impact of this decision; i.e which requirements that are added or removed from the current 21 CFR 820, and which ones that remain the same. We will clarify the scope of the regulation and how some  FDA definitions (for example of the term manufacturer) differ from those in ISO13485.  You will also get an overview of the changes that were implemented as compared to the initial proposal.

Course outline:

  • Background – why is FDA doing this?
  • Scope – which organizations need to comply to the regulation?
  • Overview of the changes – which parts of the QS Reg are impacted and in which way?
  • Consequences with respect to FDA inspections and ISO13485 certification.

Learning objectives:

After this, you will have a better understanding of the FDA revision of 21 CFR 820 and what it means to medical device manufacturers (including manufacturers of combination products)

Who should attend:

Any Quality Assurance professional with interest in FDA requirements on your Quality Management System.


Basic knowledge about Quality System Requirements



IndustryMedical Device, Pharmaceuticals

Åse Ek