Radiation-Emitting Products

Interpreting Physician Overview

Policy Guidance Help System logo

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:

  1. Have a valid State license to practice medicine.
  2. Be Board Certified in Diagnostic Radiology by an FDA-approved body or have 3 months of formal training in mammography.
  3. Have 60 category I CME credits in mammography with at least 15 obtained in the 3 years immediately prior to qualifying as an interpreting physician.
  4. 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. Mantain 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.

Interpereting Physician Qualification Worksheet


Initial Qualifications Met Before 4/28/99 (INTERIM)Initial Qualifications Met Before 4/28/99 (FINAL)
Need: ___ Valid license (any State)Need: ___ Valid license (any State)

Need one of the following:


___ Two months of training

Need one of the following:


___ 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 ___________________________
(The later of 10/1/94 or date the last initial qualification was completed)
___ 8 hours initial training in additional mammographic modality used (if applicable)
DATE COMPLETED ____________________________


Continuing Qualifications


All of the following:
___ 960 patient exams in the 24 months prior to the current date
(applicable 24 months after start date) 


___ 15 Category I CMEs in the 36 months prior to the current date
(applicable 36 months after start date)



Page Last Updated: 06/01/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English