Researchers have examined the 113 devices that the FDA recalled between 2005 and 2009 for posing serious health risks, including endangering patients’ lives. Most of the devices – 71 percent – had been approved without undergoing testing in people, the researchers reported Monday in the Archives of Internal Medicine.
That’s because under a process designed to get products on the market as soon as possible, they were deemed to be similar to another product already being sold. Only 19 percent underwent more stringent review.
Their findings revealed critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy.