FDA Update

The FDA is Seeking Public Comments

CDRH Seeks Public Comment: Increasing Patient Access to At-Home Use Medical Technologies

The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health
(CDRH) seeks input from the public, particularly patients, patient advocacy organizations, health
care providers, consumers, the medical device industry, clinical researchers, and others on
advancing health equity and facilitating access to medical devices designed to be safe and
effective when used outside of traditional clinical settings, for example, medical devices intended
for use in the home.

Advancing health equity will ensure all patients, regardless of race, sexual orientation, gender
identity, age, physical abilities, geographic location, educational background, and economic
status will have access to safe, effective, and high-quality medical technologies, including at-
home use devices, which may provide significant improvements in healthcare, quality of life, and
wellness.

Please submit all public comments to the docket (FDA-2023-N-1956), available at
Regulations.gov. The public comment period is 90 days and will end on August 30, 2023.

Questions?
For more information on: patient access to at-home use medical technologies, please visit us at:
info@mdiconsultants.com and ref: patient access to at-home use medical technologies.