Stakeholders Seek Guidance, Clarity from FDA on At-Home Medical Technologies

Stakeholders spanning various industries are urging the US Food and Drug Administration (FDA) to reevaluate its oversight of at-home medical technologies in comparison to those used in conventional clinical settings. They emphasize the need for increased clarity and predictability in the FDA's regulatory approach and the issuance of updated and new guidelines on this subject. AdvaMed, a prominent medtech lobby group, has put forth a comprehensive set of recommendations. AdvaMed calls upon the agency to establish a broader definition of at-home use devices. It points out that current FDA guidance characterizes these products as those usable outside professional healthcare facilities, encompassing settings like offices, schools, and independent living retirement homes. AdvaMed suggests various measures that the federal government can implement to enhance access to treatments and diagnostics outside clinical settings, addressing concerns related to health equity. One notable proposal is the creation of a network of community-based healthcare centers, including locations such as historically Black colleges and rural facilities.