Home > Newsletters > International Medical Device Regulatory Monitor > More Rigorous Data Needed to Support PMA, 510(k) Submissions, Expert Says
International Medical Device Regulatory Monitor
July 2012 | Vol. 20 No. 7
More Rigorous Data Needed to Support PMA, 510(k) Submissions, Expert Says
The U.S. Food and Drug Administration (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.
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