CDRH Innovation has a two-fold approach to increase patient access to innovative medical devices developed by small businesses and start-ups: (1) increase outreach to these innovators, and, (2) increase training opportunities for our staff to learn about the unique challenges start-ups face.
Below are resources available to encourage medical device innovators to request CDRH's input early in the device development process.
If you are in the process of developing an innovative medical device, CDRH offers the following two meeting options, as part of FDA's Q-Submission Program, to answer questions you may have 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 and/or application preparation.
- In addition to traditional device design questions, medical device innovators are encouraged to ask manufacturing and quality system questions during their Pre-Submission meeting. The Quality System regulation (21 CFR 820) applies to finished device manufacturers who intend to commercially distribute medical devices and covers design, manufacturing, and other quality system activities.
Payor Communication Task Force
CDRH established the Payor Communication Task Force to facilitate communication between device manufacturers and payors to potentially shorten the time between FDA approval or clearance and coverage decisions. By communicating earlier, manufacturers may design their clinical trials to produce the data required for regulatory approval or clearance and for positive coverage determinations, which may expedite patient access. We invite you to visit our Payor Communication Task Force webpage.
Additional Early Assistance Resources
If you plan to conduct research involving human subjects, information about good clinical practices and human subject protection is available at: Device Advice: Investigational Device Exemption (IDE). Other resources include:
- Using the PICOTS Framework to Strengthen Evidence Gathered in Clinical Trials - Guidance from the AHRQ's Evidence-based Practice Centers Program
- U.S. National Library of Medicine: HTA 101: Introduction to Health Technology Assessment
- Centers for Medicare & Medicaid Services (CMS): Innovators' Guide to Navigating Medicare Version 3: 2015
- Agency for Healthcare Research and Quality: Methods Guide for Comparative Effectiveness Reviews - Assessing the Risk of Bias of Individual Studies in Systematic Reviews of Health Care Interventions
- Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials. Ann Intern Med. 2010;152:726-732. doi: 10.7326/0003-4819-152-11-201006010-00232
If you have questions about early regulatory assistance available for medical device innovators, contact CDRH Innovation at CDRH-Innovation@fda.hhs.gov.
If you have specific 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.
Small Business Innovation Research (SBIR), Small Business Technology Transfer (SBTT) Grantees, Start-ups and Other Grantee Assistance
CDRH Innovation, in partnership with The National Institutes of Health (NIH), piloted programs to assist Small Business Innovation Research (SBIR) and Small Business Technology Transfer (SBTT) awardees interested in working collaboratively with CDRH to better understand the regulatory pathway and data requirements for their medical devices.
We supported the National, Heart, Lung, and Blood Institute (NHLBI) SBIR/SBTT grantees that were developing products, falling under the regulatory jurisdiction of CDRH, by providing feedback on their device development via the CDRH Pre-Submission Program.
In 2019, with the National Cancer Institute (NCI)’s SBIR Development Center, we created CARE – Connecting Awardees with Regulatory Experts. This program piloted a new opportunity for CDRH to provide regulatory feedback to NCI’s grantees.
Based on the success of these pilots, we will continue to support NIH SBIR and STTR awardees and have expanded the program to include various medical device incubators, accelerators, and others to help provide early regulatory guidance to grantees and start-ups. Besides the resources and opportunities listed on our web-page, we can work with your group to pilot other approaches.
If you have your own grant program, or incubator/accelerator, and would like to have similar opportunities with CDRH for your grantees and start-ups, contact CDRH-Innovation@fda.hhs.gov.
CDRH Exchanges with Incubators and Accelerators
CDRH Innovation is partnering with various innovation groups and accelerators to send employees to shadow start-up companies. Incubators/Accelerators are entities that support early stage companies in medical device development. CDRH employees benefit by learning how their regulatory requests and decisions impact the business decisions of the companies, and the start-ups learn about CDRH's review processes and get a better understanding of our regulatory role.
CDRH is currently looking for more incubators and accelerator sites to participate in the exchange program through CDRH's Experiential Learning Program (ELP).
If you have questions about how to join this exchange program, contact CDRH-Innovation@fda.hhs.gov.