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