Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

Harmonization of reimbursement and regulatory approval processes: a systematic review of international experiences

(2013) Bernice Tsoi et al.   Expert Review of Pharmacoeconomics & Outcomes Research

Multisociety (AATS, ACCF, SCAI, and STS) Expert Consensus Statement: Operator and Institutional Requirements for Transcatheter Valve Repair and Replacement, Part 1: Transcatheter Aortic Valve Replacement

(2012) Carl L. Tommaso et al.   JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Rethinking medical device regulation

(2012) Carl Heneghan et al.   JOURNAL OF THE ROYAL SOCIETY OF MEDICINE

Medical device regulation in Australia: safe and effective?

(2012) Richard G McGee et al.   MEDICAL JOURNAL OF AUSTRALIA

Delays and Difficulties in Assessing Metal-on-Metal Hip Implants

(2012) Joshua P. Rising et al.   NEW ENGLAND JOURNAL OF MEDICINE

Unique Device Identification in the Service of Public Health

(2012) Thomas P. Gross et al.   NEW ENGLAND JOURNAL OF MEDICINE

Here We Go Again — Another Failure of Postmarketing Device Surveillance

(2012) Robert G. Hauser   NEW ENGLAND JOURNAL OF MEDICINE

Patient Access to Medical Devices — A Comparison of U.S. and European Review Processes

(2012) Saptarshi Basu et al.   NEW ENGLAND JOURNAL OF MEDICINE

Postmarketing Surveillance of Medical Devices — Filling in the Gaps

(2012) Frederic S. Resnic et al.   NEW ENGLAND JOURNAL OF MEDICINE

Faulty hip implant shows up failings of EU regulation

(2012) D. Cohen   BMJ-British Medical Journal

How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review

(2012) Daniel B. Kramer et al.   PLOS MEDICINE

US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety?

(2012) Jona A. Hattangadi et al.   Journal of Oncology Practice

Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform: Report of a policy conference of the European Society of Cardiology

(2011) A. G. Fraser et al.   EUROPEAN HEART JOURNAL

Interactions between health technology assessment, coverage, and regulatory processes: Emerging issues, goals, and opportunities

(2011) Chris Henshall et al.   INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE

Medical Devices and Health — Creating a New Regulatory Framework for Moderate-Risk Devices

(2011) David R. Challoner et al.   NEW ENGLAND JOURNAL OF MEDICINE

Medical Devices — Balancing Regulation and Innovation

(2011) Gregory D. Curfman et al.   NEW ENGLAND JOURNAL OF MEDICINE

Medical device recalls and transparency in the UK

(2011) M. Thompson et al.   BMJ-British Medical Journal

Commentary: International collaboration needed on device clinical standards

(2011) A. G. Fraser et al.   BMJ-British Medical Journal

Europeans are left to their own devices

(2011) D. Cohen et al.   BMJ-British Medical Journal

Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review

(2010) Jonas Zajac Hines et al.   PLOS MEDICINE

Economic Evaluation for Devices and Drugs—Same or Different?

(2008) Michael Drummond et al.   VALUE IN HEALTH