Medical Devices Often Approved Before First Clinical Study’s Published: Study

A significant number of medical devices hit the market with FDA approval before clinical trials establishing that they are safe and effective are seen by the medical community, according to the findings of a new study. 

Researchers from the Imperial College in the U.K. found that 43% of medical devices approved by the FDA between 2000 and 2004 were cleared for use before clinical trials were published. The findings were presented in a report last week in the medical journal The BMJ.

Imperial College researchers looked for clinical trials for new medical devices on PubMed from January 2000 to December 2004. They identified a total of 218, of which 99 were eventually approved by the FDA. According to the findings, 78 out of the 99 devices approved, or 79%, were approved through the 510(k) process, which means that a device only needs to be substantially equivalent to an existing medical device to win approval. The researchers determined that 43 of the 99 devices were approved or cleared before a clinical trial was published.

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Because the researchers went looking for devices with published clinical trials, the study does not take into account devices that were approved without any clinical trial results being released.

“The corollary is that many devices cleared for use in patients had no clinical data accessible in the literature to support their use,” the researchers in the latest study concluded. “Without high quality clinical data available, informed shared decision making on the use of new medical devices is difficult if not impossible.”

FDA Device Approval Process Under Scrutiny

The findings comes as the FDA seeks ways to streamline the clinical trial process, particularly involving medical devices. However, recent research has raised concerns about the lack of follow through on required studies by many medical device and drug makers.

Although many of the clinical trials required by federal regulators are never completed, or not even started, the FDA often approves the products and allows them to stay on the market anyway. Therefore, many consumers receiving recently approved treatments become essential test subjects without ever being told or consenting, since they are serving as ginnie pigs for products that were never properly tested before approval.

In August 2015, a study published in the Journal of the American Medical Association (JAMA) looked at data on high-risk therapeutic devices that received premarket approval by the FDA in 2010 and 2011, determining whether manufacturers had completed required post-approval studies (PAS), which are conducted after the device is already made available to healthcare professionals and consumers.

The findings indicate that only six of 33 PAS studies required by the FDA were actually completed, and only 20 of 171 manufacturer/investigator-initiated post-market studies were reported as complete.

Those findings came about two months after an analysis published in BMJ found numerous discrepancies in data submitted to the FDA by medical device manufacturers seeking premarket approval for cardiovascular devices. Those discrepancies often included the number of participants varying in the actual study from the number reported to the FDA, substantially different results from similar FDA studies, and many of which were never peer-reviewed.

At about the same time as the 2015 BMJ report, the FDA released a report on it’s role in medical device safety. The agency says it has made significant strides in ensuring medical devices are safe and effective, including how it reviews and requires clinical trials.


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