Performance Improvement 2000. Medical Devices

01/01/2000

FDAMA Mandated User Facility Reporting Program

The Food and Drug Modernization Act of 1997 (FDAMA) required FDA's Center for Radiological Health (CDRH) to change its user facility program from universal, mandated reporting of adverse events to a program of user reporting limited to certain facilities, constituting a representative profile. Although the 1992 amendments to the Safe Medical Device Act required reporting of all events causing serious injury or death due to medical devices, FDA did not have the resources or personnel to monitor the 40,000 to 50,000 user facilities involved. Thus, the FDAMA called for a solution to this problem by asking the FDA to establish a sentinel surveillance system by identifying a sample of facilities and a more proactive surveillance network among them. Congress also required the agency to submit a progress report by late 1999 on efforts towards implementing the new sentinel system. This project has been instrumental in assessing the feasibility and effectiveness of such a reporting program.

AGENCY SPONSOR: Center for Devices and Radiological Health

FEDERAL CONTACT: Gardner, Susan
301-594-2812

PIC ID: 7108

PERFORMER: Food and Drug Administration
Rockville MD

EXPECTED DATE OF COMPLETION: 9/30/2000

Nationwide Evaluation of X-Ray Trends (NEXT)

The Nationwide Evaluation of X-Ray Trends (NEXT) is a collaborative program conducted jointly between the Food and Drug Administration (FDA) and State radiation control agencies. The study estimates the radiation dosage from diagnostic x- ray examinations, using data collected from previous NEXT surveys of different types of x-ray examinations. The data are used by public health and professional organizations in setting policy.

AGENCY SPONSOR: Center for Devices and Radiological Health

FEDERAL CONTACT: Suleiman, Orhan
301-594-3533

PIC ID: 4984

PERFORMER: Food and Drug Administration
Rockville MD

EXPECTED DATE OF COMPLETION: 9/30/2000