on Device TestingâEUR incorrectly characterized the device review process as "lax." In the published letter, Ubl says: FDAâEUR(TM)s premarket review process involves extensive review of specifications and performance-testing information, and in many cases clinical data, before being made available to patients. For the higher risk devices, FDA requires comprehensive clinical data for approval. The Government Accountability OfficeâEUR(TM)s report on FDAâEUR(TM)s review process, the focus of the article, limited its comments primarily to a small subset of 20 devices that the FDA has yet to classify, not the review process as a whole. In fact, the GAO report demonstrates that FDAâEUR(TM)s process is working as intended so that all devices are subject to the appropriate level of regulation to ensure their safety and effectiveness.