DeLauro: New GAO Report Shows FDA Must Do More to Ensure Medical Device Safety

WASHINGTON, DC—A Government Accountability Office (GAO) report released today showed that the Food and Drug Administration (FDA) must do more to ensure the safety of medical devices, said Congresswoman Rosa DeLauro (D-CT), who requested the report. DeLauro is a former chairwoman of, and still serves on, the subcommittee responsible for funding the FDA.

The report, FDA Ordered Postmarket Studies to Better Understand Safety Issues, and Many Studies are Ongoing, can be read in its entirety here.

“The FDA has a responsibility to ensure that devices are adequately tested before public marketing and broad distribution,” said DeLauro. “Unfortunately, GAO’s data highlights that new devices do not need to be proven as either safe or effective before consumers begin using them. People are not guinea pigs and we should not be rushing devices to market. I will continue to monitor this situation closely to determine whether Congress should be taking action.”

There are two kinds of studies conducted after a device has been cleared for sale: postapproval, which are ordered simultaneous to when a device goes on the market, and postmarket surveillance, which is usually ordered after a device has already been on the market for a period of time.

GAO’s findings demonstrate that the laws governing medical devices are weak and are allowing such devices onto the market without rigorous study. The findings also show that postmarket and postapproval studies often take a long time to be completed, and that companies lack incentive to find participants for their studies, contributing to the reality that medical devices can be sitting on the market without anyone having to prove that they are safe and effective. For example, the average length for postapproval studies is about three years, with the longest study taking almost seven years.


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