Tag: medical devices
FDA begins ‘real-time’ reporting of adverse event data
The Food and Drug Administration (FDA) recently announced that it has begun daily publication of...
US FDA issues first draft guidance for AI-based medical device development
The US Food and Drug Administration (FDA) has issued draft guidance that includes recommendations to...
Swiss parliament votes to accept US FDA-approved medical devices
The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Ad...
FDA issues two final guidances for including patient perspectives in medical device studies
The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations f...
