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GAO Report Concludes FDA Still Cutting Corners in Reviewing High-Risk Medical Devices

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Location: Washington, DC


GAO Report Concludes FDA Still Cutting Corners in Reviewing High-Risk Medical Devices

U.S. Rep. Frank Pallone, Jr. (D-NJ), Chairman of the House Energy and Commerce Subcommittee on Health, issued the following statement today in response to the release of a Government Accountability Office (GAO) report on medical devices. The report was required as part of the Food and Drug Administration (FDA) Revitalization Act of 2007. The New Jersey congressman was one of the lead authors of that law.

"The GAO's investigation confirms my concerns that the approval process for medical devices is woefully inadequate. For years, Congress has required high-risk medical devices to undergo stringent pre-market review, but the GAO's findings show that is simply not happening in every case.

"From 2003 to 2007, the FDA approved 228 high-risk medical devices using a less vigorous process. Since several of these devices are permanently implanted into a patient's body, it's outrageous that the FDA is cutting corners in the review process. It's time the FDA abide by the intent of the law so that we can guarantee that all medical devices are safe.

"While I am not surprised by these findings, I plan to hold hearings in my subcommittee to review the overall process, and will develop legislat


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