Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Agency issues proposed orders to reclassify intra-aortic balloon and control systems, tuberculosis IVDs and stair-climbing wheelchairs. Industry mainly supports FDA’s communications draft guidance. More regulatory news.
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Regulatory Briefs: Pre-Amendment Reclassifications; Upcoming FDA Meetings
FDA finalizes rules reclassifying intra-aortic balloon devices, external counter-pulsating devices and temporary mandibular reconstruction plates. Orthopaedic and ophthalmic device advisory panel meetings announced.
Panel Aligns With FDA On Revised Regulation For Spinal Sphere Devices, Wheelchairs
On Dec. 12, FDA’s Orthopaedic and Rehabilitation Devices panel recommended increasing its regulatory requirements for spinal sphere devices and mechanical wheelchairs and downclassifying stair-climbing wheelchairs.
Regulatory Briefs: Draft Guidances On Hearing Aids, Syphilis Tests; Upcoming Panel Meetings
FDA issues draft guidance clarifying the difference between hearing aid devices and personal sound amplification products. Agency also issues draft guidance on the use of tests to screen human cells and tissues for syphilis. Boston Sci gets a new panel date for Watchman. More regulatory news.