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Webinar Materials

• Presentation
• Printable Slides
• Transcript

Summary: On Thursday, November 7, 2019, the U.S. Food and Drug Administration (FDA) will host a webinar on the Safety and Performance Based Pathway guidances.

Background: On September 19, 2019, the FDA issued four draft guidances and updated a final guidance related to the Safety and Performance Based Pathway as part of our commitment to strengthening and modernizing the 510(k) program, as described in the FDA's Medical Device Safety Action Plan.

As a first step towards operationalizing the Safety and Performance Based Pathway, the FDA issued four draft guidances that identify performance criteria and testing methodologies for certain devices within four class II device types:

• Conventional Foley Catheters
• Cutaneous Electrodes for Recording Purposes  
• Orthopedic Non-Spinal Metallic Bone Screws and Washers
• Spinal Plating Systems

The FDA also updated the Safety and Performance Based Pathway final guidance.