• Summary
• Background
• Meeting Materials
• Comments

Summary

The U.S. Food and Drug Administration (FDA) is announcing a webinar for stakeholders to share information and answer questions about the draft guidance: Computer Software Assurance for Production and Quality System Software.

During this webinar the FDA will describe:

• the scope and purpose of the draft guidance;
• computer software assurance (CSA) as a risk-based approach to establish confidence in the automation used for medical device production or quality systems; and
• the risk-based assurance activities that may be applied to establish CSA.

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Background

The FDA believes that applying a risk-based approach to computer software used as part of medical device production or the quality system would better focus manufacturers' assurance activities to help ensure product quality while helping to fulfill the validation requirements of 21 CFR 820.70(i).

Once final, this guidance is intended to provide recommendations on computer software assurance for computers and automated data processing systems that are used as part of medical device production or the quality system. This will help foster the adoption and use of innovative technologies that promote patient access to high-quality medical devices and help manufacturers to keep pace with the dynamic, rapidly changing technology landscape, while promoting compliance with laws and regulations implemented by the FDA.

Meeting Materials

Printable slides will be made available on this webpage prior to the webinar.

After the webinar, the presentation, printable slides, and transcript will be available at CDRH Learn under "Postmarket Activities," sub-section "General Policy."

Comments

Please submit your comments regarding this draft guidance to https://www.regulations.gov, Docket No. FDA-2022-D-0795 by November 14, 2022 to ensure that the FDA considers comments on this draft guidance before it begins work on the final guidance.