Zdrowie i gospodarka · 16/12/1997

FDA Proposes to Reclassify Penile Rigidity Implant from Class III to Class II

The US Food and Drug Administration (FDA) is proposing to reclassify the penile rigidity implant, a medical device intended to treat erectile dysfunction in men, from a high-risk category to a moderate-risk category, based on new information and in accordance with the Federal Food, Drug, and Cosmetic Act.