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FDA focus on more efficient processing yields faster decisions
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SAN FRANCISCO — The U.S. Food and Drug Administration has been criticized for its ponderous movement of potential drugs and medical devices through the approval process. Recognizing this criticism, and following implementation of the Medical Devices User Fee and Modernization Act of 2002 and subsequent internal reevaluations and reorganizations, the FDA approval process for innovative technologies has been gaining speed since 2010.
“We believe the U.S. is and should remain the leading innovation leader,” Malvina B. Eydelman, MD, director of the FDA Division of Ophthalmic and Ear, Nose and Throat Devices, said at the Ophthalmology Innovation Summit meeting here.
Malvina B. Eydelman
Improvements have included streamlining premarket review; assuring predictable and consistent decision making, improving quality of submissions and clinical trial data; promoting greater transparency, interaction and collaboration between the FDA and industry before and during the premarket reviews; and improving the FDA’s understanding of new device technologies, Eydelman said.
Consequently, in Eydelman’s department, the average time to clear a 510(k) has dropped about 30% since 2010, and the average time to reach a decision on a premarket approval is about one-third less, she said. Furthermore, the percentage of filed premarket approvals that are approved, which were steadily declining since 2005, has risen more than 20% since 2010, she said.
Disclosure: Eydelman is director of the FDA Division of Ophthalmic and Ear, Nose and Throat Devices of the U.S. Food and Drug Administration.