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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Responsible Individuals For Quality Assurance Program

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Citation:

900.12(d)(1): Responsible individuals. (1) Responsibility for the quality assurance program and for each of its elements shall be assigned to individuals who are qualified for their assignments and who shall be allowed adequate time to perform these duties.

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