Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments

European medical device regulation is under scrutiny and will be re-regulated with stricter rules concerning requirements for clinical evidence for high-risk medical devices. It is the aim of this study to analyse the differences between Europe and USA in dealing with risks and benefits of new cardi...

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Veröffentlicht in:	BMC cardiovascular disorders 2014-11, Vol.14 (1), p.154-154, Article 154
Hauptverfasser:	Wild, Claudia, Erdös, Judit, Zechmeister, Ingrid
Format:	Artikel
Sprache:	eng
Schlagworte:	Austria Blood circulation disorders Cardiac arrhythmia Cardiology - instrumentation Care and treatment Comparative analysis Device Approval Diffusion of Innovation Equipment Design Equipment Safety Evidence-based medicine Evidence-Based Medicine - methods FDA approval Federal regulation Humans Marketing Marketing of Health Services Medical device industry Medical equipment Medical law Patient Safety Patients Physiological apparatus Risk Assessment Risk Factors Studies Technology Assessment, Biomedical - methods Time Factors United States United States Food and Drug Administration
Online-Zugang:	Volltext
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