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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Medical Physicist Approval Letter

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Discussion:

Upon request, FDA's Division of Mammography Quality Standards (DMQS) will review a medical physicist's credentials to determine whether or not the physicist meets the initial requirements under the MQSA regulations. After the review, DMQS will send the physicist a letter identifying the initial requirements that he or she meets. The physicist can then provide this letter to the mammography facilities he or she serves. The information identified in this letter will be accepted by the MQSA inspector as adequate evidence that the cited initial requirements are met. You will also need to supply all facilities where you provide mammography services a copy of your Board certification or a current State approval or State license. Please be aware that if your State approval or State license expires after a certain period, you must provide your facilities with a new copy of the documentation after each renewal. Consequently, the physicist will not need to provide facilities with copies of the more detailed credentials that he or she sent to us for evaluation.

This service can be particularly valuable for medical physicists who serve many facilities because it reduces the amount of paperwork that they have to provide to each of their facilities. Physicists who are uncertain about whether or not they meet the initial requirements may use this service for getting their questions related to the initial requirements answered.

We stress, however, that the decision to utilize this service is entirely yours. If you choose not to use this service, our inspectors will continue to evaluate your detailed credentials during their annual inspections of the mammography facilities you serve. Should you be interested in using this service, the following "Questions and Answers" contain additional details on the submission of your credentials that will be necessary for review.

Questions: 
  1. Must all medical physicists send documentation of their credentials to FDA headquarters for review by the mammography program?
  2. What would be the advantage of sending my credentials to the FDA headquarters for review?
  3. Will this review cover all of my MQSA personnel requirements?
  4. What documents should I send to FDA headquarters for review?
  5. How long will it take FDA to perform this review?
  6. What if one of my facilities is inspected while I am waiting to get my review back?
  7. What if this assessment of whether or not I meet the initial requirements disagrees with an earlier inspection finding?
  8. How does FDA's letter relate to the State approval letter that I already have?
  9. Where do I send my credentials for review?