CDRH Industry: Announcing the FDA Webinar to Discuss the Custom Device Exemption Final Guidance – October 14, 2014

On October 14, 2014 at 1:00 p.m., the FDA will hold a webinar to answer questions about the Custom Device Exemption final guidance. We want to hear from you, so please mark your calendars to participate. No registration is required.

Custom medical devices are designed for patients or physicians with a rare and unique pathology or physiological condition for whom there are no other appropriate medical device treatments readily available in the U.S. The Custom Device Exemption final guidanceprovides interpretations of key aspects of the exemption, including the custom device definition, the potential for multiple units of a device type (not to exceed 5 units per year), and manufacturer annual reporting requirements.

The slide presentation and audio recording of the webinar will be available on CDRH Learn website following the event.

Webinar Details:

Date:  Tuesday, October 14, 2014

Time:  1:00 PM – 2:00 PM, Eastern Time. To ensure you are connected, please dial-in at 12:45 PM.

NOTE: You must dial-in to hear the presentation and ask questions:

Dial: 888-469-1336, passcode: 6263206

To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PW8710447&p=6263206&t=c
Conference number: PW8710447Passcode: 6263206

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

Food and Drug Administration
Center for Devices and Radiological Health