900.12(a)(1)(i)(B)(1): The interpreting physician shall be certified in an appropriate specialty area by a body determined by FDA to have procedures and requirements adequate to ensure that physicians certified by the body are competent to interpret radiological procedures, including mammography.
The FDA recognizes interpreting physicians certified with specialties in radiology and diagnostic radiology by the following organizations:
- American Board of Radiology (ABR)
- American Osteopathic Board of Radiology (AOBR)
- Royal College of Physicians and Surgeons of Canada (RCPSC).
An original or copy of a certificate, a letter from one of the above boards or college, a letter from the American College of Radiology (ACR) specifically confirming that the physician is board certified by the ABR or the AOBR, or listing in the American Board of Medical Specialties (ABMS) will be acceptable documentation. Attestation is not acceptable for certification.
- FDA-approved interpreting physician certification boards have started issuing certificates that have an expiration date. If an interpreting physician allows his board certification to expire, must he or she obtain recertification to continue interpreting mammograms?