Machine-Produced Radiation

While much of machine-produced radiation is coveredby state regulations, when used on humans applicationsmanufacture of the units falls under the auspicesof the FDA. The FDA rules can be found in 21 CFR 1020.For the most part, the state regulations follow the FDAguidances when applicable, but sometimes with a sizabledelay.

Mammography forms a notable exception to thegeneral lack of federal control over machine-producedradiation in medicine. Based on the MQSA, as notedabove, the FDA sets requirements for practitioners onmammography, and failure to satisfy the requirementsprevents providers from obtaining reimbursement fromgovernment sources. The requirements for mammographyequipment are given below in the section onDiagnostic Units. In addition, there are considerablerequirements placed on the training and experience ofthe persons involved: the radiologist, the radiographer, and the medical physicist.

Radiation producing machines fall into three maincategories discussed in the following sections.