U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. News & Events (Medical Devices)
  4. Workshops & Conferences (Medical Devices)
  5. Webinar - Final Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions - February 9, 2017
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Webinar - Final Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions - February 9, 2017
February 8, 2017

Date:
February 8, 2017
Time:
7:00 PM - 7:00 PM ET

      

Webinar Materials

On Thursday, February 9, 2017, the FDA will hosted 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.

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

Back to Top