US GAO urges Caution Over EU Device Approvals

The US Congress should wait for more proof before having the Food and Drug Administration copy the European Union system of approving medical devices, says a US General Accounting Office report. After comparing the two systems of regulation, the GAO says the EU system is too new to see if it is really faster that the FDA's and whether its reviews are as rigorous.

The report, requested by Senator nancy Kassebaum, chairman of the Senate Committee on labor and Human Resources and sponsor of an FDA reform bill, says it is not yet possible to draw a meaningful conclusion. The two systems operate within different legal and policy contexts; the FDA has a public health mandate, ensuring approved devices are both safe and effective, while the EU's mission is to facilitate EU-wide trade by creating a single review process that allows devices to be marketed in all member states as well as ensuring that they are safe.

Criteria For Approval And Clearance Differ The criteria for device approval and clearance also differ. devices are generally evaluated in the EU for safety and ability to perform as the maker intends, while the FDA criteria are safety and effectiveness, an additional standard of providing benefit to patients. The EU system also relies on recognized performance standards which can be international, European or national. Showing that a device meets such standards is voluntary, but the report says this is an acceptable and often convenient way to show the device complies with the essential requirements. The US criterion of effectiveness encompasses more that the Eu standard of performing as the manufacturer intended; the US device must benefit certain patients.