Medtech insiders respond to FDA's 510(k) split-predicate ban

The FDA's new guidance against split predicates in medtech 510(k) applications gets a largely warm welcome from industry insiders.

The FDA's decision to ban so-called "split predicates" in medical device 510(k) applications was met largely with praise from members of the Medical Devices Group on LinkedIn.

A few voices in the crowd expressed concern or ambivalence about the decision, but most commenters agreed that the change "makes sense and seems fair."

Food & Drug Administration (FDA)

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

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