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  5. Webinar - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Final Guidance - August 22, 2019 - 08/22/2019 - 08/22/2019
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Webcast

Event Title
Webinar - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Final Guidance - August 22, 2019
August 22, 2019

Webinar - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Final Guidance - August 22, 2019 - 08/22/2019 - 08/22/2019


Date:
August 22, 2019
Time:
August 22, 2019
Organized By:
Organizer

Summary: On Thursday August 22, 2019, the FDA will host a webinar for device manufacturers and industry to discuss and answer questions about the Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Final Guidance.

Background: This final guidance provides recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers.  The guidance covers key aspects of ultrasound safety, including use of consensus standards to measure and report acoustic output, and the safety principle of ALARA (As Low As Reasonably Achievable) to continue to promote the safe use of ultrasonic imaging. This guidance describes the types of modifications to a diagnostic ultrasound device for which the FDA does not intend to enforce the requirement for a new premarket notification (510(k)) submission. 

This guidance is intended to encourage ultrasound manufacturers to add clinically useful modifications to their devices.  For manufacturers with an established track record of ultrasound device development, based on the submission of 510(k)s for their original devices, this can be done for certain modifications without submitting another 510(k) as the safety and effectiveness of those types of low-risk modifications is known. 

Webinar Details:

Registration is not necessary.

Date: August 22, 2019
Time: 01:00 PM EDT – 02:30 PM EDT
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.

U.S. Callers Dial:

  • 800-857-5152
  • Conference Number:  PWXW9312161
  • Passcode: 1273630

International Callers Dial:

  • 1-212-547-0162
  • Conference Number: PWXW9312161
  • Passcode: 1273630

To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW9312161&p=1273630&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.

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