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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Interpreting Physician Initial Training 60 hours of CME

Policy Guidance Help System logoCitation:

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.

Discussion:

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)

Questions: