FDA CIRCULAR NO. 2014-005

: The main purpose is to prohibit the operation of radiographic x-ray machines with tube currents below 100 mA in diagnostic radiology to ensure radiation safety and compliance with international recommendations.
: Diagnostic radiology x-ray machines with tube currents below 100 mA are affected, while those used in dental, veterinary, industrial, anti-crime, research, mobile C-arm, mammography, bone densitometry, and lithotripsy are not affected.
: The World Health Organization's (WHO) recommendations influenced the Circular, specifically their suggestion that x-ray tube current shall exceed 100 mA.
: The deadline is December 31, 2014.
: They will face appropriate sanctions as provided by the Implementing Rules and Regulations of Republic Act 9711 if they continue operation beyond December 31, 2014.
: No, initial license to operate (LTO) applications for such facilities shall not be received.
: No, mobile C-arm and specialized x-ray machines such as those for mammography, bone densitometry, and lithotripsy are exempted.
: Their LTO validity shall be only until December 31, 2014.
: The Food and Drug Administration (FDA) through its Center for Device Regulation, Radiation Health, and Research (CDRRHR) and its Regional Field Offices.
: Sanctions are based on the Implementing Rules and Regulations of Republic Act No. 9711.