The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is committed to advancing public health by helping to bring innovative technologies to market and providing reasonable assurance that the medical devices already on the market continue to be safe and effective.
CDRH Innovation facilitates activities that help accelerate patient access to safe, effective, and innovative medical devices. We do this by providing opportunities for our reviewers to increase their regulatory knowledge, and by providing early regulatory assistance to innovators and small businesses.
CDRH Innovation Activities Include:
- Payor Communication Task Force
- Parallel Review
- Activities to Support Medical Device Innovators
- FDA Innovation Challenge: Identify New Sterilization Methods and Technologies
- FDA Innovation Challenge: Reduce Ethylene Oxide Emissions
- FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder
- Innovation Pathway - Archived
- Innovation Challenge: End Stage Renal Disease - Archived
- Entrepreneurs-In-Residence - Archived
CDRH Innovation will continue to focus on facilitating activities that could help accelerate patient access to safe, effective, and innovative medical devices. For questions, additional information, or to request our presence at an event, please email CDRH-Innovation@fda.hhs.gov. Please note, all formal speaking requests will need to follow the procedures outlined here.