DA’s process for regulating medical devices has come under fire in recent years for being both too cautious and too thorough. With the launch of a new program, the agency is acknowledging that there is some truth in the former argument.
“In weighing the benefits and risks of new technologies for [patients with life-threatening or irreversibly debilitating conditions], we understand the need to place greater weight on the benefit of earlier access, and to also account for the risks of delayed access,” writes CDRH director Jeffrey Shuren, MD on the FDA website.
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