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FDA sharps device requirements

This article was originally published in The Gray Sheet

Executive Summary

FDA establishes interim policy that scales back clinical data requirements outlined in its draft guidance on sharps devices with injury prevention features. Under the interim policy, which will be in effect until FDA finalizes revisions to the draft, "a modicum" of in-use data will be required to demonstrate safety and effectiveness of the devices, FDAers say. The amount and type of data will depend upon the device's intended use. The clinical data provisions in the draft came under criticism at a May meeting of FDA's General Hospital and Restorative Devices Advisory Panel ("The Gray Sheet" May 16, I&W-1)

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