Jeff Shuren, Director at the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), has stated that increasing access to medical devices that can be used by consumers at home is a CDRH priority. Recently, FDA took steps toward this goal by issuing a call for comments on the following questions:1
- “How can the FDA support the development of medical technologies, including digital health technologies and diagnostics, for use in non-clinical care settings, such as at home?”
- “What factors should be considered to effectively institute patient care that includes home-based care?”
- “What are ways that digital health technologies can (a) foster the conduct of clinical trials remotely and (b) support local or home-based healthcare models?”
- “How can the FDA facilitate individuals accessing medical technologies in remote locations when they are unable or unwilling to access care in clinical settings?”
- “What processes and medical procedures, including diagnostics, do you believe would be ideal for transitioning from a hospital and/or healthcare setting to non-clinical care settings, for example, home use or school/work use?”
- “What medical technologies could be ideal to transition to use in non-clinical settings? What aspects of those technologies could potentially benefit from modifications to optimize use in non-clinical settings?”
- “What design attributes and user needs would facilitate the use of medical technologies, including diagnostic and therapeutic devices, for use in a non-clinical setting, for example home use?”
- “For digital health technologies, what design attributes could better facilitate their use by diverse patient populations outside of a clinical setting? What other factors are important to consider which may improve use and acceptance of different digital health technologies by diverse patient populations (for example, older adults, non-English speakers, lower literacy)?”
- “What potential methods and strategies for evidence generation and data analysis could facilitate the regulatory review of medical technologies intended to be used in non-clinical settings, for example home use or school/work use?”
CDRH’s efforts and public outreach are also consistent with its 2022–25 strategic priorities that focus on advancing health equity and “bringing health care directly to patients wherever they are.”2 As Shuren explained, “digital health technologies can help bridge the health care gap, by bringing care directly to patients, wherever they are as well as to facilitate the participation of all in clinical investigations, particularly people historically under-represented in clinical studies."3
This is an exciting time for medical device developers, investors, and the public even though FDA’s interest in home use medical technologies is not new. FDA launched its Home Use Medical Device Initiative in 2010 in response to the unique considerations and potential risks associated with the more prevalent use of device in a home setting.4 With recent advances in technologies, this is a great opportunity for companies to engage with FDA given its interest in this area and potentially seek participation in the agency’s Breakthrough Designation and Safer Technologies Program (SteP).
Comments may be submitted to the regulatory docket until August 30, 2023.5
1 Press Release: CDRH Seeks Public Comment: Increasing Patient Access to At-Home Use Medical Technologies (June 28, 2023), https://www.fda.gov/about-fda/cdrh-strategic-priorities-and-updates/cdrh-seeks-public-comment-increasing-patient-access-home-use-medical-technologies.
2 CDRH, 2022-2025 Strategic Priorities, at 13 (2022), https://www.fda.gov/media/155888/download.
3 FDA, Health Equity Forum Podcast, Episode 11: Advancing Health Equity with Medical Technologies (Mar. 30, 2023), https://www.fda.gov/consumers/health-equity-forum-podcast/advancing-health-equity-medical-technologies.
4 FDA website, Medical Device Home Use Initiative: https://www.fda.gov/medical-devices/home-use-devices/home-use-devices-initiative; see also FDA, Medical Device Home Use Initiative: White Paper (Apr. 2010), https://www.fda.gov/media/78647/download.
5 CDRH Seeks Public Comment: Increasing Patient Access to At-Home Use Medical Technologies, Docket No. FDA-2023-N-1956, https://www.regulations.gov/document/FDA-2023-N-1956-0001.
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