Two Articles Relating to FDA Approval and "Post-Approval" of Medical Devices

Wimmer Moscovitch, Et Al

Abstract


The Journal of Health Care Finance is pleased to present two companion articles by various distinguished authors.  The first article examines the cost-benefit situation with respect to the FDA’s post-approval studies for medical devices.  The second article presents perspectives concerning possible avenues for improving the effectiveness of post-market studies of medical devices.  ARTICLE #1: Assessing the Cost Burden of United States FDA-mandated Post-Approval Studies for Medical Devices (begins on page 2 of master PDF file)  ARTICLE #2: A Better, Cost-Effective Way to Evaluate Medical Devices Using Real World Data (begins on page #19 of master PDF file)


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SPECIAL NOTES REGARDING ARTICLE TITLES AND AUTHORS

ARTICLE #1: Assessing the Cost Burden of United States FDA-mandated Post-Approval Studies for Medical Devices (begins on page 2 of master PDF file)

Neil J. Wimmer, MD, Christiana Care, Division of Cardiology, Newark, DE, USA

Susan Robbins BS, Comparative Effectiveness Research Institute and Department of Cardiovascular Medicine, Lahey Clinic Foundation, Burlington, MA, USA

Henry Ssemaganda, MD, Comparative Effectiveness Research Institute and Department of Cardiovascular Medicine, Lahey Clinic Foundation, Burlington, MA, USA

Erin Yang, BS, Comparative Effectiveness Research Institute and Department of Cardiovascular Medicine, Lahey Clinic Foundation, Burlington, MA, USA

Sharon-Lise Normand, PhD, Department of Healthcare Policy, Harvard Medical School, and Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA

Michael E. Matheny, MD,Geriatrics Research Education and Clinical Center (GRECC), Tennessee Valley Healthcare System, Veteran’s Health Administration, Murfreesboro, TN; Vanderbilt University School of Medicine, Nashville, TN, USA

Naomi Herz, MSc, King's Technology Evaluation Centre, King's College London, St Thomas' Hospital, London

Joshua P. Rising, MD, The Pew Charitable Trusts, Washington, D.C., USA

Frederic S. Resnic, MD, Comparative Effectiveness Research Institute and Department of Cardiovascular Medicine, Lahey Clinic Foundation, Burlington, MA, USA; Tufts University School of Medicine, Boston, MA, USA

NOTE RE Funding Sources: This study was supported by a research grant from The Pew Charitable Trusts, Washington D.C.

ARTICLE #2: A Better, Cost-Effective Way to Evaluate Medical Devices Using Real World Data (begins on page #19 of master PDF file)

Ben Moscovitch, Officer, Medical Devices, The Pew Charitable Trusts, Washington, DC Corresponding author: 202.540.6333, bmoscovitch@pewtrusts.org

Joshua P. Rising, Director, Healthcare Programs, The Pew Charitable Trusts, Washington, DC


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