Webinar Materials

• Presentation
• Printable Slides
• Transcript

On Wednesday, July 26, from 1:00 – 2:30 p.m. ET, the FDA hosted “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 provided:

• 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.

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 [email protected].