U.S. Food and Drug Administration recently issued the following announcement.
On Thursday, March 14, 2019, the FDA will host a webinar on the final guidance entitled, "The Least Burdensome Provisions: Concept and Principles." This final guidance describes our use of the least burdensome approach to medical device regulation to remove or reduce unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval. The least burdensome approach ensures that our regulatory framework is appropriately tailored to support timely patient access to high quality, safe and effective medical devices. The guidance describes the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to the regulation of medical devices.
Webinar Details:
Date: Thursday, March 14, 2019
Time: 1:00 – 2:30 PM Eastern Time
To ensure you are connected, please dial in 15 minutes prior to the start of the webinar.
NOTE: You must dial-in to hear the presentation and ask questions:
U.S. Callers Dial: 888-950-8041
CONFERENCE NUMBER: PWXW8679760, PASSCODE: 1063322
International Callers Dial: 1-212-547-0418
CONFERENCE NUMBER: PWXW8679760, PASSCODE: 1063322
To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join.php?i=PWXW8679760&p=1063322&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 (CEU) or Certificates of Attendance for webinar attendance.
Target Audience: Industry
If you have any questions, please contact CDRH's Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or by phone at 1-800-638-2041, or 301-796-7100.
Original source can be found here.
