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Eliminating 510(k) clearance for some Class I medical devices is being considered by the Food & Drug Administration in an effort to speed agency review of new medical devices, said FDA commissioner David Kessler, M.D.
Kessler shared this information during the Health Industry Manufacturers Assn. (HIMA) annual meeting, Palm Beach, Fla., in late March. But Kessler quickly qualified his statement, adding that removing 510(k) requirements for devices is just one of several options being discussed by FDA officials to make the clearance process more efficient.
"The medical device industry is one of the few industries with a positive trade balance and I want to keep it …