April 10, 2009

On April 8, 2009, the Food and Drug Administration (“FDA”) announced its plan to review 25 types of medical devices marketed prior to 1976.  Manufacturers of these devices are required to submit information within 120 days on safety and effectiveness to the FDA so that it can evaluate the risk level posed for each device type.  Those found to be of high risk to consumers will be required to undergo the FDA’s most stringent premarket review process.

Medical Devices under Investigation

The medical devices currently under review are those that were marketed in the U.S. prior to the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976, which authorized the FDA to review new medical devices.  The products currently under investigation include:

  • Membrane lung for long-term pulmonary support
  • Intra-aortic balloon and control system
  • Ventricular bypass (assist) device
  • External pacemaker pulse generator
  • Implantable pacemaker pulse generator
  • Endosseous dental implant (blade-form)
  • Cardiovascular permanent pacemaker electrode
  • Pacemaker programmers
  • Pacemaker repair of replacement material
  • Mandibular condyle prosthesis (for temporary reconstruction)
  • Nonroller-type cardiopulmonary bypass blood pump
  • External cardiac compressor
  • External counter-pulsating device
  • Automated external defibrillator
  • Implanted blood access device
  • Sorbent hemoperfusion system
  • Cranial electrotherapy stimulator
  • Electroconvulsive therapy device
  • Female condom
  • Pedicle screw spinal system (certain uses)
  • Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis
  • Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis
  • Shortwave diathermy (certain uses)
  • Iontophoresis device (certain uses)
  • Transilluminator for breast evaluation

Purpose for FDA Review

The FDA classifies medical devices into three categories according to their level of risk.  Class III devices pose the highest level of risk and usually require a showing of safety and effectiveness before they can be marketed.  The current investigation is the first step toward assessing the risk of Class III devices, including heart valves and intraocular lenses that were sold prior to the 1976 law authorizing the FDA’s review.        

If you or a loved one suffered injuries caused by a medical device marketed prior to 1976, contact us today for a confidential and free case evaluation. 

Published November 17, 2011 by