Pathways' Pick of the Week: FDA Looks Homeward

FDA opened a docket June 1 seeking broad-based public input on strategies for shifting more devices and diagnostics to at-home use. The agency posed eight relatively open-ended questions for response by August 30. It is seeking feedback on how best to support development of home-based devices, ideas for specific healthcare procedures and diagnostics that should be shifted to the home, and strategies for collecting evidence to support home-use indications, among other topics. FDA emphasized the role of digital health technologies as central to shifting more care to home. It framed its focus on home-based care as a key pillar to achieving advancing health equity, which the device center has identified as a strategic priority. CDRH has taken some steps to advance home-based devices for years, but the efforts have picked up in the wake of the COVID-19 pandemic, which forced the agency’s hand on acceptance of more technologies used outside of conventional clinical settings. 

Home test authorized. Case in point, on June 6, FDA said it granted the first traditional premarket authorization to an at-home, over-the-counter COVID-19 test. Cue Health gained a De Novo for its home-based molecular test, 15 months after it first gained an Emergency Use Authorization for that version of the test. “This is part of the FDA’s broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing,” said CDRH Director Jeff Shuren.

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