FDA Guidance on Radiation Control Regulations: Labeling
The new article provides extensive clarifications on labeling requirements to be followed in order to ensure all the vitally important information is duly communicated to end-users.
The new article provides extensive clarifications on labeling requirements to be followed in order to ensure all the vitally important information is duly communicated to end-users.
The new article clarifies the requirements pertaining to the date of manufacture and also highlights the measurement-related matters.
The new article addresses FDA guidelines related to models and assembly procedures for diagnostic X-ray equipment, emphasizing unique model identification, assembly responsibilities, and compliance with regulatory standards.
The new article provides guidance on accidental radiation occurrences (AROs), record-keeping responsibilities, and managing defects in diagnostic x-ray systems.
The new article further describes the regulatory approach to be applied with respect to X-ray products, explaining the key concepts and ideas.
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