Radiation-Emitting Products

Our facility would like to hire a physician to interpret mammograms who did not train in a U.S. or Canadian residency program. Are there any special conditions we need to be aware of?

Policy Guidance Help System logo

Yes. There are 4 basic initial requirements for any physician to qualify to interpret mammograms under the MQSA final regulations (21 CFR 900.12(a)(1)). These requirements are:

  1. Must have a valid State license to practice medicine.
  2. Must be Board-certified in Diagnostic Radiology by an FDA-approved body or have 3 months of documented formal training in the interpretation of mammograms and in topics related to mammography.
  3. Must have 60 category I CME credits in mammography with at least 15 obtained in the 3 years immediately prior to qualifying as an interpreting physician.
  4. Must have interpreted or multi-read, under direct supervision of an interpreting physician, the mammographic examinations from at least 240 patients in the 6 months immediately prior to qualifying as an interpreting physician.

With respect to foreign-trained physicians, special conditions may exist for some of the above requirements:

  1. The physician will have to contact the State where he or she wishes to practice and satisfy all its requirements in order to obtain a State license to practice medicine.
  2. The three Boards accepted by FDA are the American Board of Radiology, the American Osteopathic Board of Radiology, and the Royal College of Physicians and Surgeons of Canada. These Boards do not have reciprocity with foreign Boards. This leaves the alternative option of documenting three months of formal mammography training. In terms of residency training, FDA accepts American or Canadian training but does not recognize programs from other countries. To meet the training requirement, the physician in question could obtain the three months of mammography training once he or she arrives in the U.S. However there are 2 other approaches he or she could take. The first involves having an organization, such as an American or Canadian radiology residency program, the Accreditation Council for Graduate Medical Education (ACGME), the Accreditation Council for Continuing Medical Education (ACCME), the American Osteopathic Association Continuing Medical Education (AOA CME), the American Medical Association Physician’s Recognition Award (AMA PRA), or a State medical society, document that the foreign training was equivalent to that of an American or Canadian program. The second approach involves the mammography facility submitting a request for an alternative standard. The facility would have to perform a detailed comparison of the foreign training received by the physician to that given by an American or Canadian program and submit that evaluation to FDA. We would then review all the submitted documents and make a decision as to whether to accept or reject the alternative standard request. The general rules for submitting alternative standard requests can be found in our regulations at 21 CFR 900.18.
  3. The 60 Category I CME hours can be included as part of the three months of training (see requirement #2 of the four basic initial requirements), although the facility will have to make sure that at least 15 hours were obtained in the 3 years prior to the physician’s beginning independent interpretation in the US.
  4. Because FDA only accepts initial and continuing experience obtained in MQSA-certified facilities and initial experience obtained in Canadian residency programs, the physician will have to meet the initial experience requirement (see requirement #4 of the four basic initial requirements) once he or she arrives in the U.S.
  5. The facility should also be aware that if it has a Full Field Digital Mammography (FFDM) unit, the interpreting physician would have to obtain 8 hours of training in that mammographic modality prior to interpreting examinations produced by the facility's FFDM unit (21 CFR 900.12(a)(1)(ii)(C)). These 8 hours of training can be included as part of the three months of training (see requirement #2 of the four basic initial requirements) or, if Category I, as part of the 60 hours of CME (see requirement #3 of the four basic initial requirements).

Once the physician meets all of the above requirements, he or she would be permitted to independently interpret mammograms. Of course, the physician would also be responsible for meeting all continuing requirements when they become applicable.

Back to Interpreting Physician Alternative to Board Certification