title: Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices.
abstract: Approved medical devices frequently undergo FDA mandated post-approval studies (PAS). However, there is uncertainty as to the value of PAS in assessing the safety of medical devices and the cost of these studies to the healthcare system is unknown. Since PAS costs are funded through device manufacturers who do not share the costs with regulators, we sought to estimate the total PAS costs through interviews with a panel of experts in medical device clinical trial design in order to design a general cost model for PAS which was then applied to the FDA PAS. A total of 277 PAS were initiated between 3/1/05 through 6/30/13 and demonstrated a median cost of $2.16 million per study and an overall cost of $1.22 billion over the 8.25 years of study. While these costs are funded through manufacturers, the ultimate cost is borne by the healthcare system through the medical device costs. Given concerns regarding the informational value of PAS, the resources used to support mandated PAS may be better allocated to other approaches to assure safety.
authors.affiliation: Christiana Care, Division of Cardiology, Newark, DE, USA.
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Wimmer
authors.affiliation: Comparative Effectiveness Research Institute and Department of Cardiovascular Medicine, Lahey Clinic Foundation, Burlington, MA, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Robbins
authors.affiliation: Comparative Effectiveness Research Institute and Department of Cardiovascular Medicine, Lahey Clinic Foundation, Burlington, MA, USA.
authors.forename: Henry
authors.initials: H
authors.lastname: Ssemaganda
authors.affiliation: Comparative Effectiveness Research Institute and Department of Cardiovascular Medicine, Lahey Clinic Foundation, Burlington, MA, USA.
authors.forename: Erin
authors.initials: E
authors.lastname: Yang
authors.affiliation: Department of Healthcare Policy, Harvard Medical School, and Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
authors.forename: Sharon-Lise
authors.initials: SL
authors.lastname: Normand
authors.affiliation: 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.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Matheny
authors.affiliation: The Pew Charitable Trusts, Washington, D.C., USA.
authors.forename: Naomi
authors.initials: N
authors.lastname: Herz
authors.affiliation: The Pew Charitable Trusts, Washington, D.C., USA.
authors.forename: Josh
authors.initials: J
authors.lastname: Rising
authors.affiliation: Comparative Effectiveness Research Institute and Department of Cardiovascular Medicine, Lahey Clinic Foundation, Burlington, MA, USA; Tufts University School of Medicine, Boston, MA, USA.
authors.forename: Frederic S
authors.initials: FS
authors.lastname: Resnic
mesh_terms: D003365:Costs and Cost Analysis; D018795:Device Approval; D004867:Equipment Design; D006801:Humans; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration