Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Printed By

US FDA Draft Guidance On Medical Device Animal Studies Is 'Confusing', Says Industry

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration's recent draft guidance on how medical device companies should design and report the results of animal studies is 'confusing', says medtech industry association AdvaMed1,2.