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FDA Approves High-Risk Devices With Few Safety Studies

FDA Approves High-Risk Devices With Few Safety Studies

August 13, 2015 — The FDA often relies on just one study to approve high-risk medical devices, according to a study published in the Journal of the American Medical Association.

Researchers looked at public data from and found 286 pre-market and post-market studies on 28 high-risk devices approved in 2010 and 2011.

On average, just one clinical trials was necessary for the FDA to approve the device. There was also wide variation in post-market studies.

For example, the FDA required 33 post-market safety studies but only six were completed within three or four years of approval. There were no post-market studies for five high-risk devices. Thirteen devices had three or fewer post-market studies. Half of the studies did not compare the new device to an existing device.

The researchers cautioned:

“Most devices have been or will be evaluated through only a few studies, which often focus on surrogate markers of disease in small numbers of patients followed up over short periods of time and study indications that differ from the original FDA-approved indication.”

Class III (“high-risk”) medical devices are supposed to be approved with a rigorous premarket approval application (PMA). Instead, many risky devices hit the market with few studies or none at all.

Last year, the FDA proposed reclassifying vaginal mesh as a high-risk medical device. The first products were approved without rigorous clinical trials because they were “equivalent” to hernia mesh, which was used for an entirely different purpose.

It was not until January 2012 — after tens of thousands of women had been seriously injured — that the FDA ordered manufacturers to conduct post-market studies to address concerns about safety and effectiveness.

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