FDA Webinar - Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Premarket Approvals - Wednesday, July 26, 2017

On Wednesday, July 26, from 1:00 – 2:30 p.m. ET, the FDA will host “An Introduction to Premarket Approvals (PMA)” webinar for developers and sponsors of class III neurological devices.  Premarket approval is the most stringent type of device marketing application required by the FDA, and is required because of the level of risk associated with class III devices.

During this webinar, the FDA will provide:

• An overview of the premarket approval review process;
• Considerations for non-clinical testing of neurological devices;
• Information about premarket approval manufacturing; and
• Discussion of post-approval studies required as a condition of a premarket approval.  

Following the presentation, FDA subject matter experts will respond to questions from attendees.

This webinar is part of the FDA’s commitment to increase transparency and clarify the regulatory process for neurological devices with the goal of assuring U.S. patients and health care professionals have timely and continued access to safe, effective, and high quality medical devices. This is the third webinar in a series for developers and sponsors of neurological devices.

More information about this webinar is available on www.fda.gov/CDRHWebinar.

As always, we appreciate your feedback. Following the conclusion of the webinar, please complete a short survey about your FDA medical device webinar experience. The survey can be found at www.fda.gov/CDRHWebinar.

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 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov.

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