FDA is considering changes to the fast-track medical device approval process called 510(k). This is popular among manufacturers because it is a faster, cheaper path to market than the premarket approval process. The approval process has drawn scrutiny from the Government Accountability Office, which last year identified 20 types of high-risk devices that slipped through FDA.
Meanwhile, Saturday marks the two-year anniversary of the Riegel v. Medtronic, the Supreme Court ruling that granted immunity to medical device manufacturers.
To see AAJ’s release see: http://online.wsj.com/article/SB10001424052748704398804575071791464778482.html .