After enactment of the Medical Device Amendments of 1976, which established three regulatory classes for medical devices, the Food and Drug Administration (FDA) has been required to classify all ...

This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...

FDA classifies medical devices based on the type of device and the level of risk it poses Three main FDA clearances for medical devices are 510(k), de novo and pre-market approval Several ASX ...

In 2022, nearly 900 medical devices were recalled by FDA, representing a 125% increase compared to 2012, which saw 399 recalls. That number included 70 Class I recalls — FDA’s highest and most serious ...