FDA to beef up quality focus in device approval process

FDA officials are enhancing their focus on quality during the medical device approval process, assures Steve Silverman, director of the office of compliance at the Center for Devices and Radiological Health. As MedCity News reports, Silverman spoke to a Minneapolis device industry audience about the agency's efforts to boost its focus on quality along with compliance. One way it will do this: A careful release of data to aid patients and providers seeking to determine which competing device is of higher quality. But Silverman said this would be more of a passive release of data, such as adverse events reports, inspection or recall data, and regulators will not issue device quality ratings. Story