PUBLIC MEETING ON DEVICE GENERAL/SPECIFIC INTENDED USES GUIDANCE UNDER CONSIDERATION BY FDA; HIMA FORMING TASK FORCE TO PROVIDE INPUT ON POLICY
This article was originally published in The Gray Sheet
Executive Summary
FDA may seek input on the types of specific intended uses covered by a general device claim through a public meeting, Joseph Sheehan, regulations staff director in FDA's Center for Devices and Radiological Health, said Feb. 4 at a Health Industry Manufacturers Association meeting in Washington, D.C. CDRH plans to publish a guidance on the subject before the Aug. 18 deadline stipulated in the FDA Modernization Act.