A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders.
FDA issued an immediately effective frequently asked questions guidance explaining its approach to inspections and manufacturing and supply chain changes during the coronavirus disease (COVID-19) [...]
A Technology Review often begins with early assessment of the technology solution, which entails confirming that the technology is feasible and has not already been developed.
Read the latest regulatory and healthcare reimbursement news, including the FDA exempts additional Class II devices from 510(k) requirements.
More Remote Monitoring Devices Added to FDA’s EUA and a Step Forward for Digital Therapeutics Reimbursement
Read the June, 2020 regulatory and healthcare reimbursement recap from Simbex, including the FDA expands guidance on remote monitoring devices for COVID-19.
International Regulators Talk of Phased Implementation & Telehealth Coverage Extends, But Usage Still Falters
The implementation of the Eudamed has been delayed by two years and the implementation of the Medical Devices Regulation has been delayed by one year.
Regulatory News MDR delay official as industry calls to push back IVDR The European Council voted 27-0 to adopt an amendment to delay the application of the Medical Devices Regulation by one year [...]