DEVICE SOFTWARE QUALITY AUDIT PROCEDURES SHOULD BE DEVELOPED THROUGH FDA/INDUSTRY MEETINGS, FDA SAYS; CLASSIFICATION TO TAKE MORE THAN TWO YEARS
This article was originally published in The Gray Sheet
Executive Summary
Medical device software quality audit procedures merit further development at workshops over the next year by FDA, manufacturer, and information technology representatives, Harvey Rudolph, deputy director of the Office of Science and Technology in FDA's Center for Devices and Radiological Health, said at a Sept. 3-4 FDA software policy workshop in Bethesda, Maryland.