Postmarket surveillance under FDAMA should be last resort to other controls -- HIMA.
POSTMARKET SURVEILLANCE SHOULD BE LAST RESORT IN FDA's "EARLY WARNING" SYSTEM, the Health Industry Manufacturers Association maintained at a Jan. 15 FDA/industry public meeting in Gaithersburg, Maryland on how to implement revisions to the agency's tracking and postmarket surveillance (PMS) programs mandated by the FDA Modernization Act (FDAMA).