Tag Archives: 510(k) program

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FDA Issues Three New Draft Guidances on the 510(k) Program

By MedTech Intelligence Staff
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The FDA has issued three new draft guidances related to the 510(k) submissions program, including Best Practices for Selecting a Predicate Device, Use of Clinical Data in Premarket Notification and Evidentiary Expectations for Implant Devices. The agency is accepting comments and will host a webinar for stakeholders on October 26, 2023, to provide more information on the guidances.

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