medical device

Taking Hearing Aids Over the Counter

Taking Hearing Aids Over the Counter

FDA proposes a new rule to permit the purchase of hearing aids without a prescription.

Addressing the Medical Device Safety Crisis

Addressing the Medical Device Safety Crisis

Scholar calls on FDA to prioritize public health by reforming medical device regulation.

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.