Radiation-Emitting Products
Interpreting Physician Overview

In order to independently interpret mammograms, one must qualify as an interpreting physician. To do this, one must have either qualified as an interpreting physician under the interim regulations prior to April 28, 1999, OR after April 28, 1999, have documented all of the following requirements:
Have a valid State license to practice medicine.
Be Board Certified in Diagnostic Radiology by an FDA-approved body or have 3 months of formal training in mammography.
Have interpreted, under direct supervision, 240 mammographic examinations in the 6 months immediately prior to qualifying as an interpreting physician OR if the physician passed his/her certifying board in diagnostic radiology at the first allowable time the 6 month period could have been anytime in the last two years of the residency program. See Sample Residency Letter – Interim Regulations and Sample Residency Letter – Final Regulations.
After meeting all the initial requirements, ALL interpreting physicians must:
1. Maintain continuing education (15 category I CME's/36 months).
2. Maintain continuing experience (960 examinations/24months).
3. Physicians failing to maintain the continuing requirements must requalify prior to performing independent mammographic interpretation.
(a) Continuing education: Must bring total up to 15 CME's/3 years.
(b) Continuing experience: Interpret 240 examinations under direct supervision or interpret a sufficient number, under direct supervision, to bring total to 960/24 months, whichever is less.
4. Maintain a valid State license to practice medicine.
All interpreting physicians shall participate in quality assurance activities as described in 900.12(d)(1)(ii).
Each mammographic facility shall designate one interpreting physician to be the lead interpreting physician, who is responsible for ensuring that the facility’s quality assurance program meets the requirements of 900.12(d-f). 21 C.F.R. 900.2(x).
Each mammographic facility shall also designate at least one interpreting physician to be the audit interpreting physician(s)), who is/are responsible for analyzing the medical outcomes audit. The reviewing interpreting physician may or may not be the lead interpreting physician. 21 C.F.R. 900.12(f)(3).
Physicians in training may work at facilities as long as they are under the direct supervision of a qualified interpreting physician.
| Interpreting Physician Qualification Worksheet | |
This worksheet may be used by facilities to help ensure that their personnel meet all applicable
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Initial Qualifications Met Before 4/28/99(INTERIM) | Initial Qualifications Met After 4/28/99(FINAL) |
| Need: ___ Valid license (any State) | Need: ___ Valid license (any State) |
Need one of the following: ___ ABR, AOBR, or RCPSC ___ Two months of training | Need one of the following: ___ ABR, AOBR, or RCPSC ___ Three months of training |
Need: ___ 40 hours CMEs (attestation allowed if CMEs obtained prior to 10/1/94) | Need: ___ 60 hours Category 1 CMEs of which 15 were earned in the past three years |
Need: ___ 240 patient exams in any 6 month period (attestation allowed if the exams were completed prior to 10/1/94) | Need one of the following: ___ 240 patient exams in prior 6 month period ___ Certified at first allowable time 240 patient exams in the last two years of residency |
START DATE ___________________________
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Continuing Qualifications
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All of the following:
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| ___ 15 Category I CMEs in the 36 months prior to the current date (applicable 36 months after start date) | |
Related Topics
Acceptable Documents for Interpreting Physicians Annual Equipment Quality Control Tests Processor Performance - Daily QC Tests Direct Supervision of Interpreting Physicians (Definition) Interpreting Physician Initial Training 60 hours of CME Interpreting Physician Responsibilities Medical Outcomes Audit Program Quality Assurance Program Repeat Analysis and Fixer Retention - Quarterly Equipment Quality Control Tests Sample Residency Letter Interim Regulations Sample Residency Letter Final Regulations Darkroom Fog Semiannual Equipment Quality Control Tests Phantom Image - Weekly Equipment Quality Control Tests







