Medical Device Approval “Fatally Flawed"

Jane Akre
July 29, 2011

In a major red flag, the Institute of Medicine (IOM) says the Food and Drug Administration’s (FDA) process for clearing medical devices and protecting public health is “fatally flawed” and needs to be replaced.

The process is little-known to the public, but the 510(k) process, as it’s called, allows the manufacturer of a medical device to fast-track the time-consuming and expensive premarket approval (PMA) and clear a device for marketing if it is “substantially similar” to one already on the market. The 510(k) relies on the credibility and integrity of a manufacturer that it has done its due diligence to assure the public will be safe. It does not generally require any evidence of safety or effectiveness.

Most people assume a device has undergone PMA similar to drugs involving clinical trials safety testing. Not so - in fact 510(k) is essentially an exchange of paperwork for clearance to market and has become the primary method of approving so-called “moderate risk” medical devices and implants. Approximately 3,000 devices made it to market this way in 2009.

The FDA’s Center for Devices and Radiological Health (CDRH), which oversees medical devices, largely depends on manufacturers to make accurate representation about the predicate device and its similarity.

And a 510(k) device even gets to stay on the market even if that “substantially similar” device has been taken off the market for causing injury to patients.

The Food and Drug Administration had asked for the IOM review after a number of red flags indicated there were problems with the process which has fast-tracked a proliferation of medical devices later taken off the market after injuring patients.

The questions IOM attempted to answer were:

  • Does the current 510(k) process protect patients optimally and promote innovation in support of public health?
  • If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally

Conclusion by the IOM

“The IOM finds the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness through the device life cycle. The IOM outlines its criteria for this framework in this report.”

Here is the report. (PDF)

The FDA was swift to react, and not favorably.

"FDA believes that the 510(k) process should not be eliminated, but we are open to additional proposals and approaches for continued improvement of our device review programs," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. #

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