The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) is committed to assuring all patients have access to safe, effective, and high-quality medical devices. This commitment involves facilitating access to medical devices designed to be safe and effective when used outside of traditional clinical settings, for example, medical devices intended for use in the home.

Access to devices outside a clinical care setting may help bridge the gap by bringing health care directly to patients, wherever they are – at home, at work, in cities, in rural communities. The effort to expand access to home use technologies is consistent with CDRH’s 2022-2025 Strategic Priority focused on advancing health equity.

Request for Public Comment

In particular, CDRH seeks comment from the public on the following questions:

• 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?

Submit Comments by August 30

Background

The FDA seeks to advance health equity by:

• Facilitating availability of and access to medical technologies for all populations,
• Empowering people to make informed decisions regarding their healthcare,
• Supporting innovation of novel and existing technologies that address health inequities, and
• Reducing barriers to increase participation by diverse populations in evidence generation.

Advancing health equity will ensure all patients, regardless of race, sexual orientation, gender identity, age, physical abilities, geographic location, educational background, and economic status will have access to safe, effective, and high-quality, medical technologies, including at home use devices, which may provide significant improvements in healthcare, quality of life, and wellness.

Questions

For questions contact cdrhhealthequity@fda.hhs.gov.