On Thursday, February 9, 2017, the FDA will host a webinar to share information and answer questions about the final guidance document, “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.” The purpose of this guidance is to clarify FDA’s approach to weighing benefits and risks for medical device product availability, compliance, and enforcement decisions. This guidance focuses on the factors the FDA may consider when making decisions related to compliance and enforcement actions for a specific medical device company, or when making decisions that may affect a medical device’s availability on the market. In addition to evaluating scientific and clinical data, the FDA may also consider the patient perspectives and other real-world data when determining a device’s safety profile.
Webinar details:
Registration is not necessary
Date: Thursday, February 9, 2017
Time: 1 to 2:30pm (Eastern Time)
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.
To hear the presentation and ask questions:
Dial: 888-889-6566; passcode 3846669 | International: 1-212-547-0325; passcode: 3846669
On the day of the webinar, use the following link to view the presentation: https://www.mymeetings.com/nc/join.php?i=PW2326652p=3846669t=c
Conference number: PW2326652
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will be available at this site on the morning of the webinar.
NOTE: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance.
Target audience: Industry
If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 or [email protected].
Thank you,
Food and Drug Administration
Center for Devices and Radiological Health
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