FDA Regulatory Pathways and Programs

Pour yourself a drink and get comfy, because this presentation covers just about everything you need to know about FDA submission strategies:

The Five Steps to Market
Crash Course in FDA Submissions
513(g) Request for Information
Breakthrough Device Program
Safety Technologies Program (STeP)
eSTAR

Webinar originally presented to the Consortium for Technology and Innovation in Pediatrics: https://www.ctipmedtech.org/





Keywords: medical devices, FDA 510 k process, medical device regulatory affairs, FDA 501 medical device regulation, FDA 510(k), medical device classification, FDA 510k clearance, regulatory affairs, FDA 510k approvals, regulatory affairs medical devices, FDA pre submission, regulatory compliance, FDA submission, FDA 510k submission guidance