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  5. Webinar - CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program - 10/26/2023
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Webinar - CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program
October 26, 2023

Date:
October 26, 2023
Time:
1:00 PM - 2:30 PM ET

Summary

On October 26, 2023, the U.S. Food and Drug Administration (FDA) will host 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 will describe the ongoing efforts to modernize the 510(k) Program that led to these new draft guidances, provide an overview of the draft guidances, and respond to questions.

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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: 

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 Details

Registration is not necessary.

Date: October 26, 2023

Time: 1:00 PM - 2:30 PM ET

Please dial in 15 minutes before the start of the call to allow time to connect.

Please click the link below to join the webinar: https://fda.zoomgov.com/j/1600235723?pwd=UXRXb2J6cHg2Tk5BL2FsVUhheDZmdz09

Passcode: TX1s&d

Please note: Participants who join the webinar using the Zoom webinar link above should use computer audio (listen through their computer speakers and speaking through computer microphone/headset).

The dial-in information provided below is for participants who will be joining the webinar by phone only.

  • U.S. Callers Dial: 833-568-8864 (Toll Free)
    • For higher quality, dial a number based on your current location:
      • +1 669 254 5252 US (San Jose)
      • +1 646 964 1167 US (US Spanish Line)
      • +1 646 828 7666 US (New York)
      • +1 551 285 1373 US
      • +1 669 216 1590 US (San Jose)
      • +1 415 449 4000 US (US Spanish Line)
  • International Caller Dial: Please check the international numbers available
  • Webinar ID: 160 023 5723
  • Passcode: 214522

Webinar Materials

The presentation, printable slides, and transcript will be 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.

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