FDA loophole led to years of unsafe medical devices

A new JAMA study says FDA medical device authorizations may not be safe for patients as a result of a loophole in the rules. The loophole is part of something called the 510(K) pathway. Researchers found it's led to a family tree of medical devices, recalled for potential patient harm — from IV tools in the hospital to a thermometer at home, the FDA began regulating medical devices in the '70s.