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Webinar Materials

• Presentation
• Printable Slides
• Transcript

Summary: The U.S. Food and Drug Administration (FDA) hosted a webinar for industry and other interested stakeholders to provide an overview of the final guidances and answer questions about the performance criteria for:

• Conventional Foley Catheters
• Cutaneous Electrodes for Recording Purposes 

Background: On August 13, 2020, the FDA issued two final guidance documents providing performance criteria for specific device types in support of the Safety and Performance Based Pathway.

As part of our commitment to strengthening and modernizing the 510(k) program, the FDA announced in February 2019 the framework for the voluntary Safety and Performance Based Pathway through final guidance. These guidances allow for implementation of the Safety and Performance Based Pathway, and provide an alternative 510(k) pathway for certain class II “moderate risk” devices to gain clearance for marketing by demonstrating that they meet modern performance criteria identified by the FDA. Under the Safety and Performance Based Pathway, a device should meet the FDA-identified performance criteria to demonstrate that it is as safe and effective as, or substantially equivalent to, other devices of the same type already on the market.