FDA Questions Third-Party Review Of Medical Devices

The Wall Street Journal: The FDA is considering ending a program that allows medical-equipment makers to have their products reviewed by third-party companies instead of by FDA officials. "The agency's concerns about the third-party reviews come as the FDA is re-evaluating its entire device-approval process. In addition, the agency has recently announced tighter regulation of some machines that deliver radiation in the wake of reports of more than 300 cases of overdoses from CT scanners at four hospitals. ... Some third-party reviewers advertise speed and a friendlier process. Imaging devices such as X-ray and MRI machines have recently accounted for more than one-third of the products in the program. Makers of these machines like it because it can enable them to get pricey equipment on the market at least a month faster. ... The Web site for one of the third-party companies, Citech Inc., says it can get a product to market 'months sooner.' The site adds: 'Third-party review is also friendlier, less adversarial, than FDA review.'"

FDA says the original intent of the program was to save taxpayers' money (Mundy and Favole, 3/15).

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