Will Class IIb See The Light Of Day? FDA Sends Mixed Messages
This article was originally published in The Gray Sheet
Executive SummaryIt remains unclear how FDA will move forward with its most controversial 510(k) reform proposals, such as creating a separate class IIb category for more complex devices, with mixed messages from the agency on whether the proposals are still on the table.
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The device center is dropping seven controversial 510(k) reform-related proposals, including creating a “class IIb” category of devices, following pushback from industry. But some of the matters are under consideration on Capitol Hill.
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