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FDA Criticized for Unsafe Medical Device Approval Process

Cheryl Clark, for HealthLeaders Media, July 15, 2010

In addition to requiring standards for device approval that match those standards required for drugs, and removing the 510(k) "predicate creep," the authors criticized several other FDA approval routes:

  • The FDA has inappropriately allowed use of "De Novo Process" in which a sponsor of a rejected product may request FDA clearance without identifying a predicate device if the device is determined to be low-risk and novel, when many are not. The authors said 52 devices have been cleared through this pathway.

  • The FDA has failed to complete regulatory proceedings for 16% of the most high risk medical devices that were in existence prior to the 1976 Medical Device Act, allowing them to continue to be used as predicate devices.

    According to a recent U.S. Government Accountability Office report, two-thirds of all class III preamendments devices cleared from FY 2003-2007 were implanted, life-sustaining or posed a significant risk.

    Responding to this report, the FDA recently initiated the process of determining whether a PMA would be required for most of the remaining devices.

  • The FDA has failed to classify in any risk category more than 200 types of preamendment devices that were overlooked in the original process, such as silicone pectoralis muscle implants, malar implants and certain vertebral body internal fixation devices.

  • The FDA's "superfluous appeal mechanism" gives manufacturers a second go for approval after FDA has rejected a device.

In conclusion the authors wrote: "A series of problems with the FDA's premarket regulation of devices at times appears to permit potentially unsafe or ineffective devices to reach the market. Each must be remedied with a mix of legislative, regulatory and discretionary approaches unique to that problem. Most importantly, CDRH should place its decisions on a secure evidence base."

The authors note that medical devices accounted for 6% of U.S. healthcare spending, or $123 billion in 2006.

The Medical Device Management Association did not respond to a request for a comment about the Public Citizen report.


Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists.
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