CDRH Medical Device Innovation Initiative
The United States is the global leader in medical device innovation and the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is committed to assuring that American patients have timely access to important new technologies and next-generation products without compromising their safety or effectiveness.
Each year, millions of American patients benefit from innovative medical devices that reduce suffering, treat previously untreatable conditions, extend lives, and improve public health. CDRH is responsible for advancing public health by facilitating innovation to help bring novel technologies to market and make the medical devices that are already on the market safer and more effective.
CDRH recognizes that transformative devices often present new scientific and regulatory challenges. The Innovation Initiative supports the development of innovative products by addressing some of the barriers that can impede a product’s timely progress to market.
The Medical Device Innovation Initiative proposes actions CDRH could take to help accelerate and reduce the cost of development and regulatory evaluation of innovative medical devices safely and based on sound science. These actions include:
- Facilitate the development and regulatory evaluation of innovative medical devices;
- Strengthen the U.S. research infrastructure and promote high-quality regulatory science; and
- Prepare for and respond to transformative innovative technologies and scientific breakthroughs.
The links below provide more information on the Medical Device Innovation Initiative and to read more about Innovation Pathway 2.0 currently being piloted on innovative end stage renal disease (ESRD) devices.
Public Workshop: Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development, June 24, 2010 Driving Biomedical Innovation: Initiatives for Improving Products for Patients New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products of 2014
- Innovation and Regulatory Science (Biologics)