The Food and Drug Administration (FDA) has released Draft Guidance regarding cybersecurity controls for medical devices on which it is seeking comments from interested parties.
The agency is seeking stakeholder feedback on the guidance, which seeks to clearly outline its recommendations for premarket submission content when it comes to cybersecurity concerns.
a >5-fold increase. The addition of motixafortide to G-CSF also allowed 88.3% of patients to undergo transplantation after only one apheresis session, compared to 10.8% in the G-CSF arm - an. | March 16, 2022
The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical.