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 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, 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.
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) and Small Business Technology Transfer (SBTT) Grantees Assistance
CDRH Innovation, in partnership with The National Institute of Health (NIH), announced a pilot program 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 device.
This program will support National, Heart, Lung, and Blood Institute (NHLBI) SBIR/SBTT grantees that are developing products falling under the regulatory jurisdiction of CDRH by providing feedback on their device development via CDRH Pre-Submission Program.
During a Pre-Submission meeting, the NHLBI SBIR/SBTT grantee will receive information from a small team of CDRH-reviewers and other medical device experts who can answer any questions about the grantee's medical device development plan and specific pre-market review questions (e.g., bench testing, animal testing, clinical study design). This feedback will assist the grantee in developing strategies for early stage development so that they may bring their innovative product to the marketplace in a timely and efficient manner.
If you are a current NHLBI SBIR/SBTT grantee, please contact your SBIR/SBBT program manager or review the notice for more information.
If you have your own SBIR/SBBT program and would like to have similar opportunities with CDRH for your grantees, contact CDRH-Innovation@fda.hhs.gov.
CDRH Exchanges with Incubators and Accelerators
CDRH Innovation is partnering with various innovation groups and accelerators to send some 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 understand 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.