Megan Coder, Vice President for Product and Policy at the Digital Medicine Society (DiMe), discusses the society’s new project aimed at researching global regulations for digital health to create a foundation for approval and patient access that can cut across regions.
The updated guidance clarifies how the program applies to medical devices that may address health inequities, as well as those that may increase access to care or provide a non-addictive treatment option to treat pain or addiction. It also clarifies the FDA’s current interpretation of the Breakthrough Device designation criteria.
The FDA CDRH is seeking input from industry and the public on expanding access to home use medical technologies. The comment period closes on August 30, 2023.
Special controls are also provided for reasonable assurance of the safety and effectiveness of the devices impacted by the reclassification.