FDA bans medtech 510(k) pathway's 'split predicates'

Medical device regulators clamp down on the 510(k) review pathway, prohibited manufacturers from splitting their primary substantial equivalence claims between multiple devices.

Federal medical device regulators finalized a new rule this week that prohibits manufacturers from using so-called "split predicates" to establish that their new products are effectively the same as devices already on the market.

Food & Drug Administration (FDA)

News Well, Regulatory/Clearance, 510(k), 510(k) reforms, Food & Drug Administration (FDA)

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