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Tougher Data Needed to Support PMA, 510(k) Submissions, Expert Says
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. In a critique of the FDA’s medical device approval process, Redberg chided the FDA for allowing high-risk devices to be brought to market with 510(k)s based on Class III preamendment devices, rather than through the more stringent PMA process.
Devices & Diagnostics Letter |
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