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Regulation Cardiology Medical Device

Clinical Trials Sought For Atherectomy Device 510(k)s In FDA Guidance

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Executive Summary

New US FDA draft guidance on 510(k)s for peripheral vascular atherectomy devices asks sponsors to submit clinical trial data due to lack of a good animal model.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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