FDA Seeks Comments on Greater Access to Medical Technologies at Home

June 6, 2023

As part of the FDA’s effort to increase access to home-use medical devices, CDRH is seeking comments from devicemakers, researchers, clinicians and the public on how to bring healthcare directly to patients wherever they are — at home, at work, in cities or in rural communities.

CDRH is looking for input on such issues as how the FDA can support medical technology development, including at-home digital health technologies and diagnostics, how digital health technologies can help remote clinical trials and support local or home-based healthcare models; and how to generate evidence and analyze data to facilitate the regulatory review of medical technologies intended for nonclinical settings.

The 90-day comment window closes Aug. 30.

Read the public comment request here.

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