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

Statement

Date: Oct. 29, 2015
Location: Washington, DC
Issues: Health and Health Care

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 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."


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