CDRH Innovation

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.

The innovation program is located in the Division of Health Equity within the Office of Equity and Innovative Development under the Office of Strategic Partnerships and Technology Innovation (OST). They provide leadership and strategic direction in innovation.

Specifically, CDRH Innovation facilitates activities that help accelerate patient access to safe, effective, and innovative medical devices by providing early regulatory assistance to innovators and small businesses and by providing opportunities for CDRH reviewers to increase their regulatory knowledge.

CDRH Innovation Activities Include:

• Medical Device Coverage Initiatives: Connecting with Payors via the Payor Communication Task Force
  • Early Payor Feedback Program
  • 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

CDRH Innovation will continue to focus on facilitating activities that can 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.