Device companies, developers take note: U.S. FDA Seeks Input on ways to increase patient access to home use medical Technologies

Lexology July 31, 2023
Sidley Austin LLP

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:

• “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?”
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