Improving Medical Device Regulation: The United States and Europe in Perspective

The 510(k) Ancestry of a Metal-on-Metal Hip Implant

(2013) Brent M. Ardaugh et al.   NEW ENGLAND JOURNAL OF MEDICINE

Devices and desires: industry fights toughening of medical device regulation in Europe

(2013) D. Cohen   BMJ-British Medical Journal

Inclusion of Comparative Effectiveness Data in High-Risk Cardiovascular Device Studies at the Time of Premarket Approval

(2012) Connie E. Chen et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Regulation of Medical Devices in the United States and European Union

(2012) Daniel B. Kramer et al.   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

Transcatheter aortic valve implantation (TAVI): risky and costly

(2012) H. Van Brabandt et al.   BMJ-British Medical Journal

Medical Device Recalls and the FDA Approval Process

(2011) Diana M. Zuckerman et al.   ARCHIVES OF INTERNAL MEDICINE

Commentary: Use of registries to investigate the past and develop the future

(2011) S. James et al.   BMJ-British Medical Journal

Commentary: The risk of over-regulation

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

Commentary: Evaluating and regulating device therapy

(2011) N. Freemantle   BMJ-British Medical Journal

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

Inclusion of Training Patients in US Food and Drug Administration Premarket Approval Cardiovascular Device Studies

(2010) Connie E. Chen et al.   ARCHIVES OF INTERNAL MEDICINE

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

(2010) Jonas Zajac Hines et al.   PLOS MEDICINE

Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices

(2009) Sanket S. Dhruva   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION