FDA is modernizing its 510(k) program and one change it is mulling is placing a limit on how old a predicate device is when manufacturers develop a new product showing substantial equivalence.
Rarely is the FDA accused of delivering a rapid assessment of a company’s technology. But that’s what happened last week when Dexcom’s mobile apps to free up users of its continuous glucose monitoring system got pre-market approval Friday afternoon. It was a move the company hadn’t expected for a couple more months and it scrambled […]
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