900.12(a)(1)(i)(C): The interpreting physician shall have a minimum of 60 hours of documented medical education in mammography, which shall include: Instruction in the interpretation of mammograms and education in basic breast anatomy, pathology, physiology, technical aspects of mammography, and quality assurance and quality control in mammography. All 60 of these hours shall be category I and at least 15 of the category I hours shall have been acquired within the 3 years immediately prior to the date that the physician qualifies as an interpreting physician. Hours spent in residency specifically devoted to mammography will be considered as equivalent to category I continuing medical education credits and will be accepted if documented in writing by the appropriate representative of the training institution.
Category I means medical educational activities that have been designated as category I by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Graduate Medical Education (ACGME), the American Osteopathic Association (AOA), a state medical society, or an equivalent organization as cited in section 900.2(g). Hours spent in residency specifically devoted to mammography will be considered as equivalent to category I.
Copies of certificates earned or other documentation from the training provider will suffice for the initial training qualification. If documentation is not available, proper attestation will be acceptable for records dated up to October 1, 1994. FDA will continue to accept a limited form of attestation for CME received after October 1, 1994, in certain cases. (see Attestation - Acceptable Uses for Personnel Requirements)
- Tumor boards are meetings in which cases of cancer or possible cancer are discussed by groups of physicians who may represent several specialties. In the case of possible breast cancer, mammograms may be reviewed during the discussion but the bulk of the time may be spent in discussing other issues such as follow-up actions. May interpreting physicians count their tumor board attendance time towards meeting the initial MQSA training requirements? If so, how much credit should be given?
- A physician is not board certified in radiology and did not have any training in mammography during residency, but has acquired 60 hours of category I continuing education in mammography of which 15 has been obtained in the last 3 years. The physician would like to begin reading mammograms. What else must the physician do before he or she can independently read mammograms?
- I am an interpreting physician who attended a technologist's mammography training course and was awarded category A credit. The regulations say my CME must be category I. Can I use category A credit toward meeting the requirement?
Attestation for Training Credits Earned for the Initial Training Requirement after October 1, 1994 Acceptable Subject Areas for the Continuing Education and Initial Training Requirements Category I (Definition) Interpreting Physician Exemption from Initial Requirements Interpreting Physician Overview