The Food and Drug Administration wants to overhaul the regulatory pathway that most medical devices follow to enter the market.
FDA looks to revamp medical device approval pathway
Currently, the FDA clears medical devices under the 510(k) process if they're substantially similar to another product already on the market. But some of those devices are decades old and may not be the best comparison to justify regulatory approval.
"Older predicates might not closely reflect the modern technology embedded in new devices, or our more current understanding of device benefits and risks," FDA Commissioner Dr. Scott Gottlieb and FDA device chief Jeff Shuren said in a joint statement.
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