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  5. Webinar - 510(k) Third Party Review Program: Final Guidance - 04/16/2020 - 04/16/2020
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Webcast

Event Title
Webinar - 510(k) Third Party Review Program: Final Guidance
April 16, 2020


Date:
April 16, 2020
Time:
1:00 PM - 2:30 PM ET

Summary

On April 16, 2020, the U.S. Food and Drug Administration (FDA) will host a webinar for device manufacturers, 3P510K Review Organizations, and industry to discuss and answer questions about the 510(k) Third Party Review Program final guidance.

Background

On March 11, 2020, the FDA issued final guidance: 510(k) Third Party Review Program. In addition, the FDA is updating the list of devices eligible for review under the 510(k) Third Party Review Program. Through these actions, the FDA has enhanced and strengthened the 510(k) Third Party Review Program for the benefit of the patient while the standard for FDA's medical device review has been maintained.

The final guidance

  • Describes the factors the FDA uses to determine device type eligibility for review by Third Party Review Organizations (3P510k Review Organizations);
  • Outlines the FDA's process for the recognition, rerecognition, suspension, and withdrawal of recognition for 3P510k Review Organizations; and
  • Ensures consistent quality of work among 3P510k Review Organizations through the Medical Device User Fee Amendments (MDUFA) IV commitments authorized under FDARA to eliminate the need for routine, substantive re-review by the FDA.

Key features of the 510(k) Third Party Review Program

  • Clarifies expectations for 3P510k Review Organizations of how to meet the FDA's standard for 510(k) eligible product review, which in turn is intended to eliminate the need for routine, duplicative re-reviews of certain information by FDA staff. The Third Party Review Program is intended to support CDRH's mission to protect and promote public health by enabling FDA to focus its internal scientific review resources on higher-risk and complex devices, while maintaining a high degree of confidence in the review of low-to-moderate risk and less complex devices by 3P510k Review Organizations.
  • Greater utilization of the voluntary Third Party Program allows the FDA to expedite patient access to certain low-to-moderate risk and less complex devices, without changing our statutory or data requirements, by reducing agency review times to 30 days or less.
  • Provides manufacturers an efficient, consistent and predictable process to request review of 510(k) submissions by accredited, FDA recognized organizations; and
  • Leverages high quality, FDA-equivalent reviews for low-to-moderate risk and less complex devices to improve the FDA's overall productivity and enable us to focus more of our time and resources on evaluating applications for more complex devices.

Webinar Details

Registration is not necessary.
Date: April 16, 2020
Time: 1:00 PM - 2:30 PM, ET

To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.

U.S. Callers Dial: 

  • 888-946-7601
  • Conference Number:  PWXW9965914
  • Passcode: 6470708

International Callers Dial:

  • 1-312-470-7136
  • Conference Number:  PWXW9965914
  • Passcode: 6470708

To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join.php?i=PWXW9965914&p=6470708&t=c

Following the webinar a transcript, recording and slides will be available at:
http://www.fda.gov/CDRHWebinar

We appreciate your feedback on our webinar program. Following the webinar, we will provide a link to a short survey about your FDA CDRH webinar experience, which should take no more than 5-10 minutes to complete. Your responses are confidential and will be used to help ensure the quality of our webinar program.

Note: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance for webinar attendance.

Target Audiences: Industry (medical device companies or distributors, technology manufacturers (including start-up companies or labs), academic and research institutions, healthcare facilities, professional societies, foundations and other non-profits

If you have any questions regarding this guidance document, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health