Researchers explore the optimal cost-benefit considerations of medical device cybersecurity risks.
Scholars advocate mandated patient access to health device data.
Scholar argues that Congress and FDA should treat risky clinical artificial intelligence tools as medical devices.
With cyberattacks on medical devices on the rise, scholars examine regulatory challenges and solutions.
FDA proposes a new rule to permit the purchase of hearing aids without a prescription.
Scholar calls on FDA to prioritize public health by reforming medical device regulation.
Scholars call for greater transparency in how FDA uses subjective evidence in treatments for brain injuries.
Responding to the coronavirus outbreak, a federal agency relaxes requirements on medical device manufacturers.
FDA clarifies enforcement priorities for medical device clinical decision support software.
Unlike new drugs and devices, combination products may fall through the regulatory cracks.