Medical Devices

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

      

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 dice@fda.hhs.gov.

Thank you,
Food and Drug Administration
Center for Devices and Radiological Health

Page Last Updated: 09/12/2018
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