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What are the requirements for accreditation and certification of mobile units? Can mobile units be accredited as additional units of a stationary facility?

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An x-ray unit may be deemed to be mobile if it is wheeled or located in a van or truck for the purpose of providing mammography service to various locations. Accreditation and certification requirements for mobile units are the same as the requirements for stationary units. They must be accredited by an FDA-approved accreditation body. 21 C.F.R. 900.11.

Whether multiple mobile units or a mobile unit operated by a stationary facility may be included under a single accreditation and MQSA certificate depends on the policy of the accreditation body.

If the AB accredits mobile units belonging to a stationary facility as additional units of that facility, then there would be one identification number for the entire facility and an additional MQSA certificate (with the same ID number) may be requested for each mobile unit. Additional MQSA certificates may be requested by contacting the MQSA Hotline at 1-800-838-7715. Facilities with State issued MQSA certificates should check with their State agencies for their policies regarding additional MQSA certificates.

Back to Application to an Accreditation Body




Page Last Updated: 08/12/2014
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