Steering a battery app through FDA validation

摘要

A recent change in outlook at the U.S. Food and Drug Administration (FDA) - the government body that regulates the use of devices and substances in medical care - has escalated the already rigorous tests applied to medical devices to new, higher levels. In 2009, FDA Commissioner Margaret Hamburg told medical device manufacturers that they bear re- sponsibility for every step in their supply chain on questions of product under-performance or malfunction. "Whether your supplier is on the other side of the world, in this hemisphere or right next door, you are responsible," she said. In 2009, 12% of the observations and 16% of the warning letters issued by the FDA were related to inadequate supplier qualifications.