Portal de Periódicos da CAPES

Assessment of US pathway for approving medical devices for rare conditions

2014; Volume: 348; Issue: jan17 1 Linguagem: Inglês

10.1136/bmj.g217

1756-1833

Thomas J. Hwang, Daniel Carpenter, Aaron S. Kesselheim,

Pharmaceutical Economics and Policy

An FDA program established in the 1990s made it easier for manufacturers to get devices for rare diseases into use. Thomas J Hwang and colleagues examine how the program has been used and what can be learnt for US and European device regulation