FDA Review Process for Medical Devices Not ‘Lax,’ New York Times Letter to the Editor States

A Jan. 16 New York Times article on a Government Accountability Office report on the FDA review process for medical devices portrayed the process as "overly lax," but that "is simply not the case," Stephen Ubl, president and CEO of the Advanced Medical Technology Association, writes in a Times letter to the editor. According to Ubl, the process "involves extensive review of specifications and performance-testing information, and in many cases clinical data, before being made available to patients," and FDA requires "comprehensive clinical data" for approval of higher-risk medical devices.

He adds that the GAO report "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 addition, the report "demonstrates that the FDA's process is working as intended so that all devices are subject to the appropriate level of regulation to ensure their safety and effectiveness," Ubl writes (Ubl, New York Times, 1/23).