Approval of High-Risk Medical Devices in the US: Implications for Clinical Cardiology

  • Benjamin N. Rome
  • Daniel B. Kramer
  • Aaron S. Kesselheim
Public Health Policy (NK Choudhry, Section Editor)
Part of the following topical collections:
  1. Topical Collection on Public Health Policy


Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls—most notably related to underperforming ICD leads—have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a “least burdensome” approach to approve new medical devices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in postmarket surveillance and comparative effectiveness research remains imperative.


Medical devices Premarket approval US Food and Drug Administration Implantable cardioverter defibrillator Patient safety High risk Clinical cardiology 



Benjamin N. Rome has received support from a Harvard Medical School fellowship.

Daniel B. Kramer has received grant support from NIH/NIA (Paul B. Beeson career development award to Dr. Kramer [K23AG045963]).

Aaron S. Kesselheim has received the following in grant support: Supported by a Robert Wood Johnson Foundation Investigator Award in Health Policy Research; Supported by a career development award from the Agency for Healthcare Research and Quality (K08HS18465-01); Supported by a grant as a Greenwall Faculty Scholar in Bioethics from the Greenwall Foundation; and Received a contract (2011) from the US FDA Center for Devices and Radiological Health to conduct comparative study of device regulation in US and EU.

Compliance with Ethics Guidelines

Conflict of Interest

Benjamin N. Rome, Daniel B. Kramer, and Aaron S. Kesselheim declare that they have no conflict of interest.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.


Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

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Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • Benjamin N. Rome
    • 1
    • 2
  • Daniel B. Kramer
    • 1
    • 2
    • 3
    • 4
  • Aaron S. Kesselheim
    • 1
    • 2
  1. 1.Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of MedicineBrigham and Women’s HospitalBostonUSA
  2. 2.Harvard Medical SchoolBostonUSA
  3. 3.Beth Israel Deaconess Medical CenterBostonUSA
  4. 4.Hebrew SeniorLife Institute for Aging ResearchRoslindaleUSA

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