Commissioner Scott Gottlieb announced the proposal in a blog posted on the FDA’s website.
(Reuters) - The U.S. Food and Drug Administration (FDA) on Monday proposed creating a new fast track to market for certain medical devices and a potential reduction in the amount of safety data required for approval.
Commissioner Scott Gottlieb announced the proposal in a blog posted on the FDA’s website. If implemented, it could save device companies millions of dollars in product testing and shave years off development times.