Division of Clinical Research

Office of the Vice President and Innovation

On September 24, 2020, the U.S. Food and Drug Administration (FDA) hosted a webinar for industry and other stakeholders interested in learning more about two final guidance documents that provide performance criteria for the following device types in support of the Safety and Performance Based Pathway: 

  • Conventional Foley Catheters
  • Cutaneous Electrodes for Recording Purposes 

You can access materials from this webinar, including the recording, presentation slides and transcript. During this webinar, the FDA provided:

  • An overview of recently issued device-specific final guidances
  • Information on 510(k) submission to the Safety and Performance Based Pathway
  • Answers to questions about the performance criteria for the final guidances

View Materials

Categories FDA Regulatory
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