US FDA’s UDI Requirements
FDA UDI regulations were released in the final UDI Rule on Septem...
BioPharma – USA/Europe/Asia Regulatory Updates, June 2024
USA
FDA Permits Marketing of First Point-of-Care Hepatitis C RNA ...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, June 2024
USA
Guidance on Laboratory Developed Tests: Small Entity Complian...
EU Portable Electronic Devices Change Requirements
Portable Electronic Devices (PED) include digital cameras, smartp...
Clinical Data Usage for Medical Device Submissions in EU and US
Clinical Data for Medical Device Submissions in EU
Clinical data ...