FDA Guidance on Radiation Control Regulations: Models and Assembly Requirements
The new article provides guidance on accidental radiation occurrences (AROs), record-keeping responsibilities, and managing defects in diagnostic x-ray systems.
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.
The article highlights the key points related to the radiation control legal framework.
The new article focuses on fluoroscopic X-ray systems and the regulatory requirements established, particularly changes effective on June 10, 2006, providing guidance on compliance, system modifications, and operational features.
The article highlights the key points associated with the regulatory status of dental ceramics, as well as the requirements they should comply with.
The final article of the cycle provides additional clarifications regarding certain specific aspects associated with the use of electronic records in the context of clinical investigations.
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