FDA Panel: Engineered Donor Heart Valves Need PMA

Friday, October 24, 2014

Source: MedPage Today

An FDA advisory committee has recommended that "more than minimally manipulated" (MMM) allograft heart valves, which currently lack a clear classification, should be regulated as high-risk devices.

If endorsed by the agency, the recommendation could subject makers of such products to costly premarket approval studies.

View All News »