TITLE 21. FOOD AND DRUGS § 360h. Notification and other remedies, 21 USCS § 360h
Summary
(a) Notification. If the Secretary determines that—
the Secretary may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the persons and means best suited under the circumstances involved, to all health professionals who prescribe or use the device and to any other person (including manufacturers, importers, distributors, retailers, and device users) who should properly receive such notification in order to eliminate such risk. An order under this subsection shall require ...