CDRH Innovation has a two-fold approach to increase patient access to innovative medical devices developed by small businesses and start-ups:
- Increase outreach to these innovators, and
- Increase training opportunities for FDA staff to learn about the unique challenges start-ups face.
If you are in the process of developing an innovative medical device, CDRH offers the following two meeting options, as part of the FDA's Q-Submission Program, to answer questions about the marketing of your specific device:
- Informational Meeting – You may request a meeting to share information with the FDA and to provide an overview of ongoing device development or help familiarize the review team with new devices that have significant differences in technology from currently available devices.
- Pre-Submission Program – You may request formal feedback from the FDA. The feedback may be provided through a face-to-face meeting, teleconference with feedback documented in meeting minutes, or in a written response. A Pre-Submission is appropriate when the FDA's feedback on specific questions is necessary to guide product development or application preparation.
- In addition to traditional device design questions, medical device innovators are encouraged to ask general quality system questions including manufacturing or production questions during their Pre-Submission meeting. The Quality System regulation (21 CFR Part 820) applies to finished device manufacturers who intend to commercially distribute medical devices and covers design, manufacturing, and other quality system activities.
CDRH also has two additional programs which may be helpful for developers of innovative medical devices:
- Breakthrough Devices Program – The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Manufacturers can expect increased interaction with the review team and prioritized review of the marketing submission.
- Total Product Life Cycle Advisory Program (TAP) – The voluntary TAP Pilot is intended to help ensure that U.S. patients have access to high-quality, safe, effective, and innovative medical devices first in the world for years to come by promoting early, frequent, and strategic communications between the FDA and medical device sponsors.
If you have questions about the regulatory process for medical devices, contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100. For general regulatory information, please visit Device Advice and CDRH Learn.
Medical Device Coverage Initiatives
CDRH established the Payor Communication Task Force (PCTF) to facilitate communication between device manufacturers and payors to potentially shorten the time between FDA market authorization and coverage decisions. By communicating earlier, manufacturers may design their clinical trials to produce the data required for market authorization and for coverage determinations, which may expedite patient access. The PCTF facilitates discussions with payors participating in Parallel Review and the Early Payor Feedback Program. For details, see Medical Device Coverage Initiatives: Connecting with Payors via the Payor Communication Task Force.
Grants and Other Funding Opportunities
CDRH has a Small Business Innovation Research (SBIR) grant program for medical device innovators. The SBIR programs encourage domestic small businesses to engage in research and development with the potential for product commercialization. Each year, CDRH’s interest areas are announced in the SBIR Omnibus/Parent Grant Solicitation. For more information, see Program Description and Research Topics Document in the SBIR/STTR Omnibus section.
The National Institutes of Health’s Small Business Education and Entrepreneurial Development (SEED) Office acts as a key facilitator and resource for small business funding for the Department of Health and Human Services (HHS). For more information, see Small Business Education and Entrepreneurial Development (SEED).
HHS has other grant opportunities which may help fund medical device development.
Small Business Innovation Research (SBIR), Small Business Technology Transfer (STTR) Grantees, Start-up and Other Grantee Assistance
CDRH Innovation, in partnership with the National Institutes of Health (NIH), pilots programs to assist Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awardees interested in working collaboratively with CDRH. CDRH helps awardees better understand the regulatory pathway and data requirements for their medical devices, and in the case of NIDA’s “Payor Introductions for NIDA Grantees” program, facilitates connection with payors.
Research Evaluation and Commercialization Hubs (REACH)
Since 2014, CDRH has supported the REACH program, which includes 8 proof-of-concept hubs with 51 universities and technical colleges from 12 states, by helping to facilitate feedback from CDRH experts on innovators proposed regulatory paths. As of July 2023, CDRH has provided feedback to over 300 grantees.
National Cancer Institute (NCI)
In 2019, with the SBIR Development Center of the National Cancer Institute (NCI), CDRH created CARE – Connecting Awardees with Regulatory Experts. This program piloted a new opportunity for CDRH to provide regulatory feedback to NCI’s grantees. As of July 2023, 85 grantees have received assistance.
National Institute for Drugs of Abuse (NIDA)
In 2021, the National Institute for Drugs of Abuse (NIDA)’s Office of Translational Initiatives and Program Innovations (OTIPI) partnered with the FDA on a pilot “Payor Introductions for NIDA Grantees” (PING). As part of this pilot, CDRH educates NIDA program managers about CDRH’s Early Payor Feedback Program. NIDA program managers notify their grantees about this opportunity to interact with payors to potentially create efficiencies in their evidence generation process as well as increase the devices’ opportunities for reaching patients.
In 2022, NIDA published a 3 million dollar funding opportunity to encourage Substance Use Disorder (SUD) innovators to engage with payors through the Early Payor Feedback Program. In 2022, NIDA referrals were around 20% of Early Payor Feedback Program participants.
We will continue to support NIH SBIR and STTR awardees and plan to expand the programs to include various medical device incubators, accelerators, and others to help provide grantees and start-ups with early regulatory feedback and payor connections opportunities.
If you have your own grant program, or incubator/accelerator, and would like to have similar opportunities with CDRH, please contact CDRH-Innovation@fda.hhs.gov.
CDRH Exchanges with Incubators and Accelerators
CDRH Innovation is partnering with various innovation groups and accelerators to send the FDA’s review staff to shadow start-up companies. Incubators/Accelerators are entities that support early- stage companies in medical device development. CDRH review staff benefit from learning how a regulator’s requests and decisions impact the business decisions of the companies. In addition, the start-ups learn about CDRH's review processes and get a better understanding of the regulatory role.
CDRH is currently looking for additional incubators and accelerator sites to participate in the exchange program. If you would like to join, or have questions about this exchange program, contact CDRH-Innovation@fda.hhs.gov.