US FDA Issues Guidance of “Assembler’s Guide to Diagnostic X-Ray Equipment”

Therapeutic Goods Medical Devices
This document supersedes Assembler’s guide to diagnostic x-ray equipment: responsibilities of assemblers, distributors, and dealers of diagnostic x-ray equipment under the federal performance standard (DHHS Publication FDA 81-8144, November 1980).
It provides recommendations on the general responsibilities of manufacturers and assemblers of diagnostic x-ray equipment and the policy on the assembly of certified diagnostic x-ray equipment.
Manufacturers and assemblers of diagnostic x-ray equipment should consider these recommendations as it represents the current thinking of the FDA on the topic.
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