A sports device to ‘protect the brain’ illustrates a major problem with the FDA de novo pathway

A sports device to ‘protect the brain’ illustrates a major problem with the FDA de novo pathway

The Q-Collar worn by some NFL players highlights consumer confusion — and a lack of transparency — around FDA decisions.

FDA’s De Novo Pathway Faces Scrutiny After Approval of Q-Collar Brain Injury Device

The U.S. Food and Drug Administration’s (FDA) de novo p […] The post FDA’s De Novo Pathway Faces Scrutiny After Approval of Q-Collar Brain Injury Device first appeared on GeneOnline News. The post FDA’s De Novo Pathway Faces Scrutiny After Approval of Q-Collar Brain Injury Device appeared first on GeneOnline News.