Panel Backs FDA’s Suggestion Of Class II Stapler Status
A US FDA panel unanimously agreed that surgical staplers should be reclassified into class II on 30 May, backing FDA recommendations.
You may also be interested in...
The US agency reclassified the device from low-risk class I to moderate-risk class II after reviewing tens of thousands of adverse event reports.
The US FDA hopes to finalize or issue draft guidance documents on about 30 topics in fiscal year 2021.
Three patients have filed suit against Medtronic in recent weeks alleging they were injured by malfunctioning surgical staplers made by the company. The lawsuits add to recent scrutiny of the device type’s safety.