AdvaMed: Expedited PMA Device Pathway Should Apply To 510(k)s

The Advanced Medical Technology Association (AdvaMed) said FDA's proposed expedited program for premarket approval medical devices is too narrowly tailored and should be expanded to include devices cleared through the 510(k) pathway. Patient and consumer advocates, however, criticized the program, saying device approval standards are already too low. The agency in April released a guidance document outlining an expedited access premarket approval program for medical devices that are intended to treat or diagnose a life-threatening or irreversibly debilitating disease or...