US FDA's Gottlieb Takes Digital Device Questions From Senators At Cures Hearing
Executive Summary
The commissioner explained to senators he is trying to go beyond the 21st Century Cures Act to further encourage development of innovative digital devices.
You may also be interested in...
Draft Clinical-Decision-Support Software Guide Paves A Path, But May Need Some Work
US FDA dropped three big digital-health guidances related to medical software as part of its initiative to help to streamline a path to market for a sector that is "increasingly embraced" by the health system and needs regulatory certainty, according to agency. But initial industry reaction to perhaps the most highly anticipated of the document, on clinical-decision-support software, is somewhat critical.
Draft Clinical-Decision-Support Software Guide Paves A Path, But May Need Some Work
US FDA dropped three big digital-health guidances related to medical software as part of its initiative to help to streamline a path to market for a sector that is "increasingly embraced" by the health system and needs regulatory certainty, according to agency. But initial industry reaction to perhaps the most highly anticipated of the document, on clinical-decision-support software, is somewhat critical.
US FDA Moves On HDE, IRB, Reprocessing 'Cures' Provisions
FDA stepped up efforts to implement the 21st Century Cures Act device provisions with actions to formalize an expansion of the Humanitarian Device Exemption program to include devices treating conditions that affect up to 8,000 patients, increase flexibility for the institutional review board process and specify validation requirements for certain reusable devices.