Radiation-Emitting Products

If a facility is unable to resolve a consumer’s "serious complaint," how is the complaint then handled?

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If a facility is unable to resolve a serious complaint to the consumer’s satisfaction, the consumer may file the complaint with the facility’s accreditation body. The consumer should be able to obtain adequate directions from the facility for filing serious complaints with the accreditation body. Section 900.4(g), under accreditation body standards, established requirements for actions that accreditation bodies must take to resolve consumer complaints that have been referred to them. The final regulations do not prescribe any one particular method for accreditation bodies to use because FDA believes that flexibility will permit each accreditation body to establish a system that works best for the facilities it accredits and the patients it serves. The accreditation body and/or a consumer may forward a serious complaint to the FDA or the State Certifying Agency. FDA notes that nothing in the MQSA or the regulations precludes FDA, the State Certifying Agency, or a State from investigating complaints.

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Page Last Updated: 07/23/2014
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