Tag Archives: implants

FDA Logo

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

By MedTech Intelligence Staff
FDA Logo

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.

Continue reading