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Thu, Jul 03, 2025

Class III

Home » Topics » Regulatory » Class III
  • Fda sign
    June 9, 2021
    By Mark McCarty

    Multiple device types face prospect of class III designation after FDA advisory hearing

    The FDA’s two-day advisory hearing yielded recommendations for risk designation for a number of product types, such as plunger-like joint manipulators, which received a unanimous endorsement for a class III designation. The advisory panel was split on the risks associated with electro-acupuncture stimulators, which the FDA must now decide whether to classify as a class III device, a move that would force a number of existing devices into clinical trials for an expensive and time-consuming PMA application.

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