Lawmakers Urge FDA to Improve Predictability in Device Approvals Process
A bipartisan, bicameral group of lawmakers sent a letter to Food and Drug Administration Commissioner Margaret Hamburg urging the agency to improve regulatory certainty and predictability in the medical device approval process.
The group of 41 lawmakers was led by Reps. Anna G. Eshoo (D-Calif.) and Erik Paulsen (R-Minn.), and Sens. Amy Klobuchar (D-Minn.) and Scott Brown (R-Mass.), co-chairmen of the Congressional Medical Technology Caucus. The letter was dated Nov. 3.
“We share your commitment to ensuring safe and effective medical devices are available to patients. However, we are very concerned about recent declines in FDA performance,” the lawmakers wrote. “Increased review times, inconsistent expectations, and poor communication from the FDA are causing a lack of confidence and instability in the industry.”
The lawmakers wrote that “there must be a least burdensome approach” to balance risk and benefit without crippling the entire industry.
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