Will 21CFR820 be fully replaced by ISO 13485?

In February 2022 FDA published a proposal to amend 21 CFR 820, the FDA Quality System Regulation (QS Reg) for Medical device manufacturers. What the FDA is proposing is that ISO 13485:2016 shall be incorporated in the regulation by reference. It doesn’t mean the 21CFR820 will disappear or be removed, but it will change. Recently it was announced that the final rule is expected to be published in December 2023. But when and how should medical device companies get prepared, to transition?

Course description:

In this webinar, you will learn about the proposal and get an overview of what FDA intends to do. The FDA has proposed removals from the current 21CFR820, added and removed definitions and comments about potential changes to 21 CFR 4, CGMP for Combination products. All of this will be covered in the webinar. You will also get a brief introduction to how FDA moves the regulatory process forward with the proposed rule as a starting point, the comment period, the processing of all submitted comments, a potential final rule and the corresponding expected time for implementation.

Course outline:

• Background – why is FDA doing this
• Overview of the changes – which parts of the QS Reg will change, and in which way?
• The regulatory process – how a proposed rule is moved forward to a final rule
• How this may affect Combination products and 21 CFR 4

Learning objectives:

After this, you will have a better understanding of the FDA proposed rule to amend 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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