Radiation-Emitting Products

Acceptable Subject Areas for the Continuing Education and Initial Training Requirements

Policy Guidance Help System logo

Interpreting Physician Requirements

900.12(a)(1)(i): Initial qualifications.

900.12(a)(1)(i)(B)(2) [OR] Have had at least 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.

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 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.

900.12(a)(1)(ii): Continuing experience and education.

900.12(a)(1)(ii)(B): All interpreting physicians shall maintain their qualifications by meeting the following requirement: Following the third anniversary date of the end of the calendar quarter in which the requirements of paragraph (a)(1)(i) of this section were completed, the interpreting physician shall have taught or completed at least 15 category I continuing medical education units in mammography during the 36 months immediately preceding the date of the facility’s annual MQSA inspection or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility will choose one of these dates to determine the 36-month period. This training shall include at least six category I continuing medical education credits in each mammographic modality used by the interpreting physician in his or her practice.

900.12(a)(1)(ii)(D): Units earned through teaching a specific course can be counted only once towards the 15 required by paragraph (a)(1)(ii)(B) of this section, even if the course is taught multiple times during the previous 36 months.

900.12(a)(1)(iv): Reestablishing qualifications.

900.12(a)(1)(iv)(B): Interpreting physicians who fail to meet the continuing education requirements of paragraph (a)(1)(ii)(B) of this section shall obtain a sufficient number of additional category I continuing medical education credits in mammography to bring their total up to the required 15 credits in the previous 36 months before resuming independent interpretation.

Back to Top Arrow


Radiologic Technologist Requirements

900.12(a)(2)(ii)(A)(B) and (C): Mammography requirements. All mammographic examinations shall be performed by radiologic technologists who meet the following mammography requirements: Have, prior to April 28, 1999 qualified as a radiologic technologist under paragraph (a)(2) of this section of FDA’s interim regulations of December 21, 1993, or completed at least 40 contact hours of documented training specific to mammography under the supervision of a qualified instructor. The hours of documented training shall include, but not necessarily be limited to:

(A) Training in breast anatomy and physiology, positioning and compression, quality assurance/quality control techniques, imaging of patients with breast implants;

(B) The performance of a minimum of 25 examinations under the direct supervision of an individual qualified under paragraph (a)(2) of this section; and

(C) At least 8 hours of training in each mammography modality to be used by the technologist in performing mammography exams and

900.12(a)(2)(iii)(A) and (C): Continuing Education Requirements:

(A) Following the third anniversary date of the end of the calendar quarter in which the requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section were completed, the radiologic technologist shall have taught or completed at least 15 continuing education units in mammography during the 36 months immediately preceding the date of the facility’s annual MQSA inspection or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility will choose one of these dates to determine the 36-month period.

(C) At least six of the continuing education units required in paragraph (a)(2)(iii)(A) of this section shall be related to each mammographic modality used by the technologist.

900.12(a)(2)(iii)(B): Continuing education requirements. (B) Units earned through teaching a specific course can be counted only once towards the 15 required in paragraph (a)(2)(iii)(A) of this section, even if the course is taught multiple times during the previous 36 months.

900.12(a)(2)(iii)(D): Requalification. Radiologic technologists who fail to meet the continuing education requirements of paragraph (a)(2)(iii)(A) of this section shall obtain a sufficient number of continuing education units in mammography to bring their total up to at least 15 in the previous 3 years, at least 6 of which shall be related to each modality used by the technologist in mammography. The technologist may not resume performing unsupervised mammography examinations until the continuing education requirements are completed.

Back to Top Arrow


Medical Physicist Requirements

900.12(a)(3)(i)(B)(2): Have 20 contact hours of documented specialized training in conducting surveys of mammography facilities.

900.12(a)(3)(ii)(B)(2) Forty contact hours of documented specialized training in conducting surveys of mammography facilities.

900.12(a)(3)(ii)(B)(2) Alternative Initial Qualifications. Prior to April 28, 1999, have … Forty contact hours of documented specialized training in conducting surveys of mammography facilities and, …

900.12(a)(3)(iii)(A): Continuing education. Following the third anniversary date of the end of the calendar quarter in which the requirements of paragraph (a)(3)(i) or (a)(3)(ii) of this section were completed, the medical physicist shall have taught or completed at least 15 continuing education units in mammography during the 36 months immediately preceding the date of the facility’s annual inspection or the last day of the calendar quarter preceding the inspection or any date between the two. The facility shall choose one of these dates to determine the 36-month period. This continuing education shall include hours of training appropriate to each mammographic modality evaluated by the medical physicist during his or her surveys or oversight of quality assurance programs. Units earned through teaching a specific course can be counted only once towards the required 15 units in a 36-month period, even if the course is taught multiple times during the 36 months.

900.12(a)(3)(iv)(A): Medical physicists who fail to maintain the required continuing qualifications of paragraph (a)(3)(iii) of this section may not perform the MQSA surveys without the supervision of a qualified medical physicist. Before independently surveying another facility, medical physicists must reestablish their qualifications as follows: (A) Medical physicists who fail to meet the continuing educational requirements of paragraph (a)(3)(iii)(A) of this section shall obtain a sufficient number of continuing education units to bring their total units up to the required 15 in the previous 3 years.

Back to Top Arrow


Discussion:

All continuing education credits (category I for interpreting physicians) related to the diagnosis or treatment of breast disease or other areas that will aid facility personnel in improving the quality of mammography, will be acceptable toward meeting the continuing education requirement.

Initial training must be in topics directly related to the regulated areas of mammography as specified in the regulations above.

Back to Top Arrow


Questions:

  1. Are there specific subject areas that are acceptable for continuing medical education and others that are not acceptable?
  2. What information items must a training/CME/CEU certificate contain before it is considered acceptable documentation toward meeting an initial or continuing requirement?

Inspector Instructions:

The inspector will NOT have to review the individual lectures or topics within a course if the certificate documenting the program clearly indicates it is in one of the areas listed in question 1 above. The inspector should apply the total number of CME/CEU listed on the certificate (category 1 for interpreting physicians) toward the continuing education requirement.

Example 1:

If the program certificate states the person was granted 15 CME/CEU for a program or course entitled, “Update in Mammography”, “Update of Breast Cancer”, “New Technologies in the Evaluation of Breast Disease”, “Interventional Mammography”, “Breast Imaging”, or “MRI or Ultrasound of the Breast”, that certificate should be accepted as meeting the continuing education requirement.

Example 2:

If the 15 CME/CEU course was entitled “Update in MRI” or “Developments in Ultrasound”, the inspector should ask the facility for further documentation (a course brochure or outline should be sufficient) to determine how much of the course could be considered breast related.

Back to Top Arrow

Page Last Updated: 06/13/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.