Medical device manufacturers spent more than $33 million last year and used 225 lobbyists to pressure lawmakers to support the Food and Drug Administration’s current practice of allowing moderate-risk devices to be approved without thorough testing for safety and efficacy. The practice has come under fire in recent months, in particular by consumer groups who argue that the agency’s expedited approval process puts patients at risk for serious injury or death. This debate is currently being weighed by members of congress, who will also consider the FDA’s proposal to remedy the situation. The agency is proposing a fee increase for ... Read More
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