FDA Unveils Guidance on Diagnostic X-Ray Equipment

The FDA issued draft guidance to clarify radiation control regulations for diagnostic x-ray systems and their major components, including recordkeeping, reporting, manufacturing, importing and installation requirements for “electronic products.” 

The Food, Drug, and Cosmetic Act defines diagnostic x-ray systems as both a medical device and an electronic product.

The draft guidance considers specific topics of importance to sponsors of diagnostic x-ray equipment, including certification, labeling, records, defects and specific components such as beam limiting devices.