The global COVID-19 public health emergency brought about many changes including a relaxation of FDA regulation of slide scanners and displays in digital pathology.
A notice was recently placed in the Federal Register by the FDA through Health and Human services soliciting a 90-day comment period to discuss permanently waving FDA regulation over certain medical devices.
We will be discussing the significance of these possible changes with Richard Morroney, Director of Regulatory Compliance at Inspirata.