The Center for Devices and Radiological Health (CDRH), the section of the Food and Drug Administration (FDA) responsible for the regulation of medical devices, has issued a request for public comments on expanding patient access to medical technologies intended for use by patients in their homes. The June 1, 2023 notice from CDRH includes a list of specific questions on which the agency is requesting feedback and can be found here.
CDRH has increasingly focused on health equity as a driver for medical device regulatory policy, especially since the COVID-19 pandemic required increased development, authorization, and distribution of diagnostic and therapeutic devices for at-home use. Indeed, Jeff Shuren, the CDRH director, has mentioned the Center’s efforts towards greater health equity often in recent speaking engagements and interviews. This request for public comment further indicates that CDRH is seriously contemplating regulatory changes that will increase access to health technologies while maintaining acceptable standards of safety and effectiveness.
The post-pandemic period is an opportune moment for FDA to consider further rules and policies to guide the production and marketing of home-use devices. Demand for and development of new health technologies that are intended for use in a consumer’s home, including digital health and diagnostic devices, have risen dramatically, in line with similar demand for telehealth services (for example, see here and here). Furthermore, FDA’s key guidance on the development of at-home use devices, Design Considerations for Devices Intended for Home Use, was published in November 2014 and should be updated to account for changes in relevant technology and the rising popularity of direct-to-consumer health and wellness products and services over the past almost-decade.
All stakeholders interested in influencing CDRH’s efforts to develop rules and policies to help expand access to home-use health technologies should consider submitting comments in response to the Center’s request. Comments may be submitted via Regulations.gov to docket number FDA-2023-N-1956 and will be accepted until August 30, 2023.