Performance Improvement 1999. Medical Devices

02/01/1999

TITLE: FDAMA Mandated User Facility Reporting Program

ABSTRACT: FDAMA mandated that CDRH change its current user facility reporting from a universal program to a sample of user facilities constituting a representative profile of facilities. On September 30, 1998, CDRH completed a year of data collection study designed to identify barriers to user reporting and to see whether or not the quality of the data would improve once the barriers were removed.

AGENCY SPONSOR: Center for Devices and Radiological Health

FEDERAL CONTACT: Susan Gardner

PHONE NUMBER: 301-594-2812

PIC ID: 7108

PERFORMER ORGANIZATION: Center for Devices and Radiological Health, FDA, Rockville MD

PROJECTED DATE OF COMPLETION: 1/31/99
 

TITLE: Continuation of the Mammography Quality Standards Act of 1992

ABSTRACT: During FY 1998, the Food and Drug Administration (FDA) initiated new work requirements to accommodate additional regulations under FDA's GPRA-style program, the Mammography Quality Standards Act of 1992 (MQSA). These additional requirements consist of developing standards to authorize states as certifying bodies, thereby ensuring that mammography facilities comply with the final quality standards as implemented by the FDA. Analyses of the impacts of the enabling regulations will assist the agency in ensuring that proposed rules will minimize the impact on state regulatory bodies, while maintaining acceptable levels of facility quality. This work will include a methodology for estimating costs of regulations associated with authorizing states as certifying bodies. The following costs will be estimated: (1) inspecting facilities in certifying areas, (2) applying to become a certifying state, (3) the impact on national inspection fees after states acquire certification authority, and (4) rescinding authorization.

AGENCY SPONSOR: Office of Planning and Evaluation

FEDERAL CONTACT: Steve Tucker

PHONE NUMBER: 301-827-5339

PIC ID: 6080.2

PERFORMER ORGANIZATION: Office of Planning and Evaluation, FDA, Rockville MD

PROJECTED DATE OF COMPLETION: 9/30/99
 

TITLE: Nationwide Evaluation of X-Ray Trends (NEXT)

ABSTRACT: The Nationwide Evaluation of X-Ray Trends (NEXT) is a collaborative program conducted jointly between the FDA and state radiation control agencies. Data from this program are used to estimate the radiation dosage from diagnostic x-ray examinations associated with 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: Orhan Suleiman

PHONE NUMBER: 301-594-3533

PIC ID: 4984

PERFORMER ORGANIZATION: Center for Devices and Radiological Health, FDA, Rockville, MD

PROJECTED DATE OF COMPLETION: 12/20/99