900.12(a)(1)(i)(B)(2): The interpreting physician shall have a minimum of 3 months of documented formal training in the interpretation of mammograms and in topics related to mammography. The training shall include instruction in radiation physics, including radiation physics specific to mammography, radiation effects, and radiation protection. The mammographic interpretation component shall be under the direct supervision of a physician who meets the requirements of paragraph (a)(1) of this section.
Formal training is a structured documented education program that includes mammographic interpretation, academic course work, and/or continuing medical education (course work and CME includes but is not limited to the topics listed in the citation above).
Some of the ways that formal training requirements may be met and documented include the following:
- A letter or other documentation from the physician’s American or Canadian residency program documenting that the physician has met the 3 months of training in mammography. For purposes of meeting the training requirements, FDA considers 3 months to equal 12 weeks, which also equals 420 hours (35 hours x 12 weeks). The 3 months of training can occur any time during the residency program and does not have to be in one continuous block of time. The letter can come from either the current officials or from those in authority at the time of the physician’s residency. It should come from a responsible residency program official who has the authority to sign for the department and should indicate the signer’s title (e.g. Chairman of Program, Director of Residency Education, Director of Mammography Section).
- Documented CME in mammography totaling 420 hours that may include certificates, letters, etc. These CME units must be category I as recognized by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Graduate Medical Education (ACGME), the American Osteopathic Association Continuing Medical Education (AOA CME), the American Medical Association Physician’s Recognition Award (AMA PRA), state medical society, or equivalent.
- Documentation of successful completion of formal mammography training courses as recognized by the ACCME, ACGME, AOA CME, AMA PRA, state medical society, or equivalent.
- FDA suggests that documentation of formal training in radiation physics, including radiation physics specific to mammography, radiation effects, and radiation protection may be used to satisfy up to 90 hours of the total 420 hours training requirement.
- Documentation establishing that a combination of the physician’s residency training, formal training, and CME total the equivalent of 3 months (420 hours).
Attestation may not be used to document that the interpreting physician satisfies the alternative to board certification.
- A physician is not board certified in radiology and had less than three months of training in mammography during his or her residency in radiology. Since residency, the physician has had many hours of continuing medical education. Can these continuing education units be added to the training in residency to satisfy the initial three month training requirement?
- During my residency I had 3 months of a combined chest/mammography rotation. Can I count all 3 months toward meeting the initial requirement?
- Do the 3 months of mammography training have to be performed during the last two years of the residency program?
- 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?