QMSR – The FDA revision of 21 CFR 820 in relation to ISO 13485:2016
On January 31, 2024, the FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating by reference, ISO 13485:2016.
The FDA will begin to enforce the QMSR requirements from February 2, 2026. Until then, manufacturers are required to comply with the QS regulation.
Will ISO13485:2016 certification be sufficient to demonstrate compliance with QMSR?
Can an approved FDA inspection be used to demonstrate compliance with the standard?
Are manufacturers of components and raw materials for medical devices in scope?
This webinar will help you find the answers to these questions and many more.
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.
Prerequisites:
Basic knowledge about Quality System Requirements
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