• Summary
• Background
• Webinar Materials
• Comments

Summary

On October 26, 2023, the U.S. Food and Drug Administration (FDA) held a webinar for device manufacturers and other stakeholders to describe the FDA's ongoing efforts to modernize the premarket notification [510(k)] Program, and to provide an overview of three new draft guidances that the FDA believes will enhance the predictability, consistency, and transparency of 510(k) review. These draft guidances focus on best practices for selecting a predicate device, recommendations for when clinical data may be necessary in a 510(k) submission, and evidentiary expectations for 510(k) implant device submissions. The FDA described the ongoing efforts to modernize the 510(k) Program that led to these new draft guidances, provided an overview of the draft guidances, and responded to questions.

Background

As part of the FDA's ongoing commitment to modernize the 510(k) Program, also described in our Medical Device Safety Action Plan, on September 7, 2023, the FDA issued three draft guidances: 

• Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
• Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
• Evidentiary Expectations for 510(k) Implant Devices

Issuing these draft guidances marks an important step in the Center for Devices and Radiological Health's ongoing commitment to optimize the clarity, predictability, and consistency of the 510(k) Program as we implement the Medical Device User Fee Amendments 2022 (MDUFA V).

Each guidance focuses on an area of 510(k) review that was identified through public feedback as a topic where clarity and transparency would be helpful.

Webinar Materials

The presentation, printable slides, and transcript are available at CDRH Learn under "How to Study and Market Your Device", sub-section "Premarket Notification (510k)."

Comments

Submit public comments on the draft guidances under the docket numbers below at www.regulations.gov by December 6, 2023, to ensure that the FDA considers your comments on the draft guidances before it begins work on the final versions of the guidances.

• Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: FDA-2023-D-3134
• Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: FDA-2023-D-3133
• Evidentiary Expectations for 510(k) Implant Devices: FDA-2023-D-3132