FDA Circular No. 2017-013
Guidelines on the Issuance of Clearance for Customs Release of Radiation Devices by the Food and Drug Administration - Center for Device Regulation, Radiation Health and Research
I RATIONALE / BACKGROUND
Pursuant to Section 1(a) of Presidential Decree (PD) No. 480 entitled "Creating Radiation Health Office in the Department" dated 06 June 1974 as amended by PD No. 1372 and under Republic Act No. 9711 also known as "The Food and Drug Administration Act of 2009", the Center for Device Regulation , Radiation Health, and Research (CDRRHR) of the Food and Drug Administration (FDA) is empowered to regulate the import and export of radiation devices that can be ionizing such x-ray devices and non-ionizing such as laser, ultrasound, scanners and infrared radiation devices and others.