Radiation-Emitting Products

What documents should I send to FDA headquarters for review?

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Please refer to the acceptable documentation table in the Medical Physicist section of the PGHS for a detailed listing of appropriate documentation for the different requirements. Two questions in particular have been raised previously about this documentation. They are:

  1. Must I provide a transcript or some similarly detailed document from my school to show that I have the required semester hours of physics or that my degree is in an acceptable field or both?

If you send us a copy of your diploma and it clearly states that your degree is in physics or any of its specialties, such as medical or health physics, we will accept that as sufficient proof that (1) your degree is in an acceptable field and (2) you have the required hours of physics.

If the copy of your diploma shows that your degree is in one of the other fields (chemistry, engineering, radiation science) accepted in the regulations, this will be sufficient proof that your degree is acceptable. However, we will also need a transcript or other college document to determine whether you have sufficient hours of physics.

If the copy of your diploma does not indicate the field of your degree or indicates a field other than those identified in the regulations, we will need a transcript to determine whether you have sufficient hours in physics and a statement from the degree granting institution, (or the Committee on Accreditation of Medical Physicists Education Programs (CAMPEP), World Education Testing, or by one of the professional certifying bodies approved by FDA) that your degree can be considered to be in a "physical science," as defined in the regulations.

  1. Can I attest to any requirements?

You can attest to contact hours of training in mammography surveys received and surveys performed before October 1, 1994. In addition, a sole owner of a physics consulting business can attest to surveys that he or she performed between October 1, 1994 and April 28, 1999. These attestations should be on a FDA-recommended form or one with the same elements. It should include as many details as you can remember.

NOTE: It is expected that if you can remember you did "x" number of surveys, you should also be able to remember the locations, although perhaps not the exact dates.

Back to Medical Physicist Approval Letter

Page Last Updated: 08/12/2014
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