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U.S. Department of Health and Human Services

Radiation-Emitting Products

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What criteria does FDA use to determine if facilities meet the MQSA requirements for dealing with consumer complaints?

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To meet the requirements for dealing with consumer complaints, facilities must provide written documentation that describes their system for recording, maintaining, and resolving patients' complaints. The documentation must include the instructions that are, or would be, provided to patients describing how to proceed with referral of serious unresolved complaints to the accreditation body. The documentation must also include the procedures that are, or would be used by the facility to report serious unresolved complaints to their accreditation body.

If the facility has received serious complaints after 4/28/99, it must be able to produce records indicating that they are following their system and are maintaining the serious complaint for 3 years.

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