CDRH Industry: Reminder - Webinar on Draft Guidance: "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions"

On Monday, July 11, 2016, the FDA will host a webinar to share information and answer questions about its draft guidance titled "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions." This draft guidance released on June 15, 2015, focus on the factors the FDA may consider when making decisions related to compliance and enforcement actions for a specific medical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 general. The agency believes that greater transparency about the process and purpose behind such assessment will maximize patient safety by helping industry improve their medical device products and by increasing access to high quality medical devices for patients.

Webinar Details:

Registration is not necessary

Date: Monday, July 11, 2016
Time: 2:00-3:30 PM, Eastern Time

To hear the presentation and ask questions:
Dial in: 877-917-9491; passcode: 8433891 | International 212-287-1619; passcode: 8433891

On the day of the webinar, use the following link to view the presentation:
https://www.mymeetings.com/nc/join.php?i=PW8827733&p=8433891&t=c

Conference number: PW8827733

Following the webinar, a transcript and the video recording will be available at http://www.fda.gov/CDRHWebinar.

Please note the FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance for webinar attendance.

If you have any general questions about the FDA’s regulation of medical devices, please contact CDRH’s Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health