Regulatory News In Brief
This article was originally published in The Gray Sheet
FDA down-classifies implanted blood access devices. Pacemaker programmers and implantable pacemaker pulse generators are up-classified to require PMAs.
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Chart updating FDA’s progress and decisions in classifying the final set of preamendment devices.
U.S. District Court rules in FDA’s favor on 510(k) clearance rescission. Gastroenterology & Urology Devices panel to meet in June. More regulatory news.
FDA is proposing to require pre-market approval applications for three class III, pre-amendment device types in the cardiovascular and neurologic device spaces.