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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Consumer Complaints

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Citation:

900.12(h)(1)(2)(3)(4): Consumer complaint mechanism. Each facility shall:

(1) Establish a written and documented system for collecting and resolving consumer complaints.

(2) Maintain a record of each serious complaint received by the facility for at least 3 years from the date the complaint was received.

(3) Provide the consumer with adequate directions for filing serious complaints with the facility’s accreditation body if the facility is unable to resolve a serious complaint to the consumer’s satisfaction.

(4) Report unresolved serious complaints to the accreditation body in a manner and timeframe specified by the accreditation body.

Questions:

  1. How is a "serious complaint" defined?
  2. If a facility is unable to resolve a consumer's "serious complaint," how is the complaint then handled?
  3. May consumer complaints be handled by a third party acting on behalf of the facility?
  4. Does the FDA require a specific format be used for the consumer complaint mechanism?
  5. Does the FDA require a specific system be used for the consumer complaint mechanism?
  6. What criteria does FDA use to determine if facilities meet the MQSA requirements for dealing with consumer complaints?
  7. Is a facility required to maintain records of serious consumer complaints as outlined in the quality assurance record keeping requirements?
  8. How long must a facility maintain records of serious consumer complaints?
  9. What is an example of an acceptable system for collecting and resolving consumer complaints?
  10. Does the complaint mechanism have to be posted?