In an attempt to protect consumers from the dangers of defective medical devices, the U.S. Senate recently proposed draft legislation that would require manufacturers to conduct ongoing safety studies of medical devices even after the device has obtained the approval of the U.S. Food and Drug Administration (FDA). The legislation was drafted, in part, as […]

When a manufacturer wishes to introduce a new medical device or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected, the manufacturer must provide the U.S. Food and Drug Administration (FDA) with a Premarket Notification (PMA) in the form of a 510(k) submission […]