La FDA de EE. UU. publica una guía para ensambladores de equipos de rayos X de diagnóstico

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.