Radiation-Emitting Products

Must a facility submit the results of its annual medical physicist survey to its accreditation body on an annual basis?

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No. Due to recommendations from the National Mammography Quality Assurance Advisory Committee and the Institute of Medicine, FDA intends to propose deleting the requirement for annual submission of physicist surveys and in the interim, intends to exercise enforcement discretion as to this requirement as of July 1, 2007. Facilities are reminded that even after that date, they must continue to have the physicist survey performed annually and to submit the results of the physicist survey as part of the initial and reaccreditation process (21 CFR 900.4(e)(1)). Facilities must also follow their accreditation body’s procedures for updating the body when significant changes take place in the facility (section 354(e)(3) of the MQSA).

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Page Last Updated: 08/07/2014
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