New Study Confirms: FDA Medical Device Approval Process Flawed

Houston, TX (Law Firm Newswire) December 30, 2014 – Studies are again criticizing the Food and Drug Administration (FDA), saying its fast-track process for medical devices approves many that do not meet regulatory standards.

The National Center for Health Research reports that a worrying majority of medical devices approved under the FDA’s fast-track process lack publicly available safety documentation. Without this documentation, doctors and hospitals cannot accurately assess the risk a device poses to patients.

“The FDA gets a lot of pressure from medical device companies that want to beat the competition to market,” commented Richard LaGarde, a defective products attorney. “Sadly, despite previous warnings on this issue, this new study shows that the FDA is still doing a poor job of putting patient safety first.”

Previously, a major study called the FDA’s fast-track medical device approval process “fatally flawed.” That study, published in 2011, attributed a growing number of device failures and recalls to inadequate testing, according to Reuters.

The FDA commissioned the 2011 report after major headlines brought publicity to a number of massive medical device recalls.

But upon receipt of the 2011 report, the FDA immediately rejected the findings and continued using the controversial fast-track approval process with few improvements. Last month, FDA officials announced at a medical device conference that they would be searching for ways to make the medical device approval process even faster.

The latest study from the National Center for Health Research looked at more than a thousand devices approved under the fast-track process, and found that 84 percent lacked publicly-available documentation showing why the device should be considered safe.

“At the end of the day, the manufacturer is responsible for ensuring that the device is safe,” said LaGarde. “Nonetheless, it is frightening to know how easy it is for a company to have a device declared safe by the FDA, even when the device does not meet the FDA’s own standards.”

Currently, most medical devices are approved under the fast-track process.

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