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If All the Parts Have Been Replaced, Is It Still the Same Appliance?

Summary and Comment |
February 5, 2014

If All the Parts Have Been Replaced, Is It Still the Same Appliance?

  1. Harlan M. Krumholz, MD, SM

According to a study of FDA approval of cardiac electronic implantable devices, many of the models in current use were not required to undergo clinical testing.

  1. Harlan M. Krumholz, MD, SM

The FDA designates a medical device as Class III if it “presents a potential, unreasonable risk of illness or injury.” For such devices, manufacturers are required to submit clinical data to support their claims through a premarket approval (PMA) process. However, if changes to approved Class III devices are considered incremental innovations, they can bypass the PMA requirement of clinical data via a supplement pathway.

These investigators used the FDA database to determine the frequency by which supplement pathways are used for approval of changes to cardiac implantable electronic devices (CIEDs; including implantable cardioverter-defibrillators, pacemakers, and cardiac resynchronization therapy devices) and the characteristics of the approved changes.

Between 1979 and 2012, the FDA approved 77 original PMA applications and 5829 supplement applications for CIEDs. Of the supplements, 76% involved changes to design or materials. The median number of supplements per PMA was 50; in 2012, nearly 80% of the original PMA devices were subject to ≥1 supplement. The St. Jude Rialta lead, which was recalled, was one of 78 supplemental changes to the original device.

Comment

These findings show that many of the devices used today were approved without requiring the manufacturers to submit clinical data in support of their claims. As the authors rightly conclude, this study reinforces the importance of postapproval surveillance of devices approved via the supplement pathway.

  • Disclosures for Harlan M. Krumholz, MD, SM at time of publication Consultant / Advisory board United Healthcare Equity ImageCor Speaker's bureau Centrix Grant / research support FDA; NIH-NHLBI; Commonwealth Fund; The Catherine and Patrick Weldon Donaghue Medical Research Foundation; Robert Wood Johnson Foundation; Medtronic Editorial boards BMJ.com/us; American Journal of Managed Care; American Journal of Medicine; Archives of Medical Science; Central European Journal of Medicine; Congestive Heart Failure; Critical Pathways in Cardiology; Current Cardiovascular Risk Reports; JACC: Cardiovascular Imaging; Journal of Cardiovascular Medicine; Circulation: Cardiovascular Quality and Outcomes Leadership positions in professional societies American Board of Internal Medicine (Chair, Assessment 2020 Task Force); American College of Cardiology (CV Research and Scholarly Activity, and Lifelong Learning Oversight Committee); American College of Physicians (CV Research and Scholarly Activity); American Heart Association (CV Research and Scholarly Activity); Centers for Medicare & Medicaid Services (Heart Care Technical Expert Panel); Oklahoma Foundation for Medical Quality (Heart Care Technical Expert Panel); VHA, Inc. (Center of Applied Healthcare Studies External Advisory Board)

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