Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions
Posts published in “USA”
CDRH’s Regulatory Science Priorities
EU-U.S. COOPERATION – Exploring trade opportunities, from medical devices to the Internet of Things
EU MDR/IVDR: US Raises ‘Serious Concerns,’ Urges 3-Year Implementation Delay
Medical Device User Fee Rates for Fiscal Year 2020
Updated FDA Resources for Third Party Review Organizations
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment
Postmarketing Safety Reporting for Combination Products
Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions
FDA Recognizes AAMI Standard and TIR