medical device

Using Subjective Evidence in FDA Review

Using Subjective Evidence in FDA Review

Scholars call for greater transparency in how FDA uses subjective evidence in treatments for brain injuries.

FDA Relaxes Rules on Ventilators for COVID-19

FDA Relaxes Rules on Ventilators for COVID-19

Responding to the coronavirus outbreak, a federal agency relaxes requirements on medical device manufacturers.

Resolving Regulatory Confusion Over Medical Software

Resolving Regulatory Confusion Over Medical Software

FDA clarifies enforcement priorities for medical device clinical decision support software.

The Problem with Regulating Combination Products

The Problem with Regulating Combination Products

Unlike new drugs and devices, combination products may fall through the regulatory cracks.