FDA-Required Physician Qualifications for Mammography - 10/31/2003


The Food and Drug Administration's (FDA) regulations that went into effect April 28, 1999, under the Mammography Quality Standards Act (MQSA) have a unique exemption that may impact whether a radiology resident may be qualified to legally interpret mammograms immediately upon completion of his or her residency training. In addition to licensure, certification (or formal training) and formal CME, the FDA requires that a physician interpret, under direct supervision, the mammograms from 240 patients in the six months immediately before he or she starts interpreting mammograms. However, if the physician passes his or her board exam in diagnostic radiology at the first allowable time, the FDA allows the interpretation of these 240 mammograms to be within a 6-month period anytime in the last two years of the residency program. A summary of the FDA requirements follows along with examples of documentation you must provide to your facility for the annual MQSA inspection. You can find more complete information on the FDA's MQSA regulations on the FDA Policy Guidance Help System at http://www.fda.gov/cdrh/mammography/robohelp/START.HTM.

Physician Qualifications for Interpreting Mammograms

(if initially qualified after the FDA's Final rules, April 28, 1999)

  Requirements Documentation Examples
Initial Qualifications Credentials
  1. State medical license, and
  2. Board certification/initial training
    1. Board certification in diagnostic radiology (ABR, AOBR or RCPSC), or
    2. 3 months formal training in mammography
  • State license/copy with expiration date
  • Letter from state licensing board
  • Pocket card/copy of license
  • Original/copy of certificate
  • Letter from certifying board
  • Letter from ACR
  • Listing in ABMS directory
  • Letters or other documents from US or Canadian residency programs (see sample below)
  • Documentation of formal mammography training courses
  • Category I CME certificates
Initial Medical Education 60 hours category I CME
  • Include instruction in interpretation of mammograms, breast anatomy, pathology, physiology, technical aspects of mammography, QA and QC
  • 15 hours must have been obtained within 3 years of qualifying to interpret
  • If obtained during residency, hours are acceptable if documented by program
  • Letter from residency program (see sample below)
  • CME certificates
  • Letter or other document confirming in-house or formal training (category I)
Initial Experience
  1. 240 exams under direct supervision in the 6 months before starting to interpret mammography, or
  2. If physician passed boards at first allowable time, 240 exams under direct supervision in a 6-month period anytime during last 2 years of residency before starting to interpret mammography
  • Letter or other document from residency (see sample below) or training program or mammography facility – done under direct supervision
New Modality Training (e.g., digital) 8 hours of training
  • Mammography modality specific CME certificate (category I or II)
  • CME certificates (category I or II) plus agenda, course outline or syllabus
  • Letters from CME granting organizations
  • Letters, certificates or other documents from manufacturers or other formal training courses
Continuing Experience 960 examinations/24months
(Physicians failing to maintain continuing experience must requalify prior to performing independent mammographic interpretation.)
  • Letter, table, facility logs or other documentation from residency or training program or mammography facility
Continuing Education General 15 category I CME's/36 months (Physicians failing to maintain continuing education must requalify prior to performing independent mammographic interpretation.)
  • CME certificates (category I)
  • Letters from CME granting organizations
Modality specific (e.g., digital) Include 6 category I CME in each mammographic modality used by the interpreting physician
  • Mammography modality specific CME certificate (category I)
  • CME certificates (category I) plus agenda, course outline or syllabus
  • Letters from CME granting organizations

Sample Residency Letter – Final Regulations

[Official Letterhead of Residency Program]

{..Date of Letter..}

 

To Whom It May Concern:

 

Dr. { name } successfully completed his/her residency in diagnostic radiology on { date }. During the period of his/her residency program { inclusive dates }, Dr. { name } received the following training and experience specific to mammography:

1. At least three months { or may include exact amount of training } of training in the interpretation of mammograms, including instruction in radiation physics, radiation effects, and radiation protection.

[NOTE: this paragraph may be deleted if the resident has passed the diagnostic radiology certifying examinations and become a diplomat of the American Board of Radiology (ABR), the American Osteopathic Board of Radiology (AOBR), or the Royal College of Physicians and Surgeons of Canada (RCPSC).]

2. At least 60 hours of documented continuing medical education in mammography.

[NOTE to residency program director: These 60 hours may be included in the three months of training described in #1, it does not have to be an additional 60 hours of training.]

3. Read or interpreted, under the direct supervision of an interpreting physician, the mammograms from the examinations of at least 240 patients within the 6-month period of { give dates of 6-month period },

or,

if the resident physician passed the certifying board examination in diagnostic radiology at the first allowable time, the 6-month period could have been any time within the last 2 years of the residency program { give dates of 6-month period }.

[NOTE: The "first allowable time" means the earliest time that a resident physician is eligible to take the certifying examination.]

________________________________________

[Signed by an official of the Residency Program]

________________________________________

[Must include signing official's title: e.g., Chairman of Program, Director of Residency Education, Director of Mammography Section]

©FDA DMQRP