Radiation-Emitting Products

What criteria will FDA use to determine that facilities meet the MQSA requirements for assigning responsibilities to quality assurance personnel?

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Facilities must provide the following documentation: 

  1. The names of the lead-interpreting physician, medical physicist(s), quality control technologist(s), audit interpreting physician(s) and any other facility personnel with delegated quality assurance responsibilities. 
  2. A statement of responsibilities. Because the regulations already specify the responsibilities of the lead-interpreting physician, medical physicist(s), quality control technologist(s), and audit interpreting physician(s), the facility does not have to restate the responsibilities of these individuals. However, if the facility delegates quality assurance responsibilities to someone other than the lead-interpreting physician, medical physicist(s), quality control technologist(s), or audit interpreting physician(s), a statement of responsibilities for that individual(s) has to be provided.

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Page Last Updated: 08/12/2014
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