How to TAP into FDA and NIH Resources Supporting Breakthrough Medical Device Development

Medical device developers must achieve several regulatory and financial milestones to bring their devices to patients and healthcare providers. The NIH and the FDA/CDRH are holding a free educational webinar to share information and resources with medical device innovators that may help with some of these challenges. Invited speakers from CDRH will present information on best practices for the following:  

• Early-stage regulatory submissions
• Investigational Device Exemptions (IDE)
• Early Feasibility Studies
• FDA Breakthrough Program

CDRH speakers will also introduce the Total Product Life Cycle Advisory Program (TAP) Pilot,  a new program aimed at de-risking the path to device commercialization, followed by Q&A. NIH speakers will provide information on funding opportunities through SBIR/STTR and additional product development and support services available to innovators. This webinar will be held on Monday, May 20, from 11:30 a.m. to 1:30 p.m. ET. Both FDA and NIH presentations will be followed by moderated Q&A sessions.