Consumers Union Gears Up To Go After 510(k) Program, Urges MDUFA Markup

Posted 20 January 2012 | By Alexander Gaffney

Consumers Union, best known for their Consumer Reports publication, is launching a campaign to persuade Congress to force manufacturers using the 510(k) medical device regulation pathway to subject their products to the same premarket safety and efficacy tests that are required of pharmaceutical products.

The 510(k) pathway is used by medical device manufacturers, and requires that manufacturers notify the US Food and Drug Administration (FDA) that they plan to market a medical device that is "substantially equivalent" to predicate devices. This pathway does not require additional safety or efficacy testing unless FDA determines that the device is not substantially equivalent.

The Consumers Union campaign seems to borrow from the Director of FDA Center for Devices and Radiological Health, Jeffery Shuren, by calling for FDA to stop the public from being "used as guinea pigs" when it comes to medical device safety and effectiveness. Shuren made remarks in early 2011 that the European Medicines Agency (EMA) was using EU citizens like "guinea pigs" by failing to subject devices to adequate testing.

Consumers Union calls for concerned citizens to contact Congress to urge them to mark up the Medical Device User Fee Act (MDUFA) to "improve the quality, safety and effectiveness" of medical devices by "demanding standards for most medical devices be brought in line with prescription drugs."

The letter goes on to demand "substantial evidence"-not "reasonable assurance"-standards be used in the approval process, improved monitoring of devices via a "unique-identifier system for implanted devices", device registries for implanted devices, retention of current conflict of interest standards and safety improvements funded through user fees.

Other information provided by Consumers Union expands upon these recommendations and demands.



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