We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » Tougher Data Needed to Support PMA, 510(k) Submissions, Expert Says
Tougher Data Needed to Support PMA, 510(k) Submissions, Expert Says
June 22, 2012
The FDA needs to insist on more quality data in 510(k) premarket notification and premarket approval (PMA) applications and provide real-time postmarket surveillance data that is transparent, Rita Redberg, chief editor of the Archives of Internal Medicine and professor of medicine at the University of California, San Francisco, told the 2012 PharmedOut Conference in Washington, D.C.