Zdrowie i gospodarka · 15/01/2021

FDA Proposes Permanent Waiver of Premarket Notification Requirements for Certain Medical Devices During COVID-19 Public Health Emergency

The FDA is seeking public comment on a proposal to exempt additional medical devices from premarket notification requirements, expanding access to these devices during the ongoing COVID-19 pandemic and paving the way for further science-based reform of the 510(k) program.