The United States is the global leader in medical device 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 making the medical devices that are already on the market safer and more effective.
Each year, millions of American patients benefit from innovative medical devices that reduce suffering, treat previously untreatable conditions, extend lives and improve public health. Recognizing that innovative medical devices present new scientific and regulatory challenges, the Center’s 2010 Strategic Priorities included fostering the development of medical devices to respond to unmet public health needs and hiring an Associate Director for Technology and Innovation to coordinate activities that facilitate the development of innovative medical devices in the U.S. In February 2011, CDRH published the Medical Device Innovation Initiative White Paper and launched the Innovation Pathway. Both provided principles to help accelerate breakthrough medical devices reach patients in a safe, timely and collaboratively manner.
Below are a few of CDRH Innovation’s accomplishments:
- In October 2011, CDRH launched its first Entrepreneurs-In-Residence (EIR) Program. From October 2011- April 2012, the first cohort (EIR-1) consisted of 20 representatives from industry, academia, venture capital and other stakeholders working alongside 13 CDRH staff and management. Together they cultivated new ideas regarding collaboration with industry “early and often” that would promote innovation and provide patients in the U.S. with access to high-quality, safe, and effective medical devices of public health importance first in the world.
- In April 2012, CDRH launched the second version of Innovation Pathway (IP 2.0). Three products were selected from the Innovation Challenge: End-Stage Renal Disease to participate in the IP 2.0 pilot program. The developers of these three products collaborated with the Center on the development of a benefit-risk profile to help guide future studies and map out a regulatory path forward (a Data Development Plan) for their product. In November 2014, the IP 2.0 pilot program successfully concluded with all three participating end-stage renal disease medical device developers reporting the program stimulated technical enhancements and significantly shortened their product’s pathway to market.
- CDRH's EIR-Program Two (EIR-2) convened from October 2012- April 2013 with 18 representatives from industry, academia, venture capital and other stakeholders and 17 CDRH staff and management to support CDRH’s 2013 Strategic Priorities. The members of EIR-2 were divided into three subgroups to identify current problems and their underlying causes and develop potential recommendations for the following critical areas impeding medical device regulation and patient access in the U.S.:
1. Streamlining clinical trials
2. Streamlining FDA approval to reimbursement
3. Striking the right balance between pre- and post-market requirements
The recommendations of EIR-2 are reflected in CDRH’s 2014-2015 Strategic Priorities, which include strengthening the clinical trial enterprise and striking the right balance between premarket and post market data collection.
- In July, 2013, CDRH Innovation’s Payer Communication Task Force (PCTF) was created to facilitate communication between device manufacturers and Payers. Payers include public payers such as Centers for Medicare & Medicaid Services (CMS), private health plans, health technology assessment groups (HTAs), and others who provide input into coverage and reimbursement decisions during the clinical trial development phase. The goal of PCTF is to collect data that will support FDA approval or clearance and reimbursement determinations in the same clinical trial. In addition, the PCTF also oversees Parallel Review with the CMS.
The principles piloted under CDRH Innovation are that are now leveraged in the Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions and Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval guidance documents.
CDRH Innovation will continue to focus on facilitating activities that could help accelerate patient access to safe and effective innovative medical devices.
For questions or additional information about CDRH Innovation, please email CDRH-Innovation@fda.hhs.gov.
Expedited Access Pathway Program Driving Biomedical Innovation: Initiatives for Improving Products for Patients Questions and Answers about the Medical Device Innovation Initiative
- Innovation Initiative Remarks - Jeffrey Shuren, M.D., J.D., Director FDA's Center for Devices and Radiological Health (2/8/11)
Innovation at FDA