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

This week, the U.S. Food and Drug Administration released 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.

The FDA believes sharing this information with medical device companies and other stakeholders will help maximize benefits and reduce risks to patients, as well as improve the quality of medical devices.

The FDA will discuss this final guidance document at a webinar scheduled on DATE. Following a brief presentation, the FDA will respond to questions.   Registration is not necessary.

Webinar details:

• 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
• Conference number: PW2326652 
• To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PW2326652&p=3846669&t=c

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.

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