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 seeks to foster the development of medical devices to respond to unmet public health needs and to address the new scientific and regulatory challenges of bringing devices to market. We do this by increasing the regulatory science capacity of our reviewers, and providing assistance to early innovators and small businesses.
Specifically, under CDRH Innovation, the Center coordinates activities that help decrease the time between FDA approval and coverage, streamline clinical trials, and strike the appropriate balance between premarket and postmarket data collection.
Other CDRH Innovation Activities Include:
- Innovation Pathway (2011) - Archived
- Innovation Challenge: End Stage Renal Disease (2012) - Archived
- Entrepreneurs-In-Residence (2011-2016) - Archived
- Payer Communication Task Force
- Early Regulatory Assistance for Medical Device Innovators
CDRH Innovation will continue to focus on facilitating activities that could help accelerate patient access to safe, effective, and innovative medical devices. For questions or additional information about CDRH Innovation, please email CDRH-Innovation@fda.hhs.gov.
Expedited Access Pathway Program Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Guidance for Industry and Food and Drug Administration Staff(PDF - 500KB) Driving Biomedical Innovation: Initiatives for Improving Products for Patients Questions and Answers about the Medical Device Innovation Initiative Innovation at FDA