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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Reestablishing the Interpreting Physician Continuing Education Requirement

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Citation:

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.

Discussion:

Requalification does not affect or change the date on which such individuals met their initial qualification requirements, therefore, the starting dates on which such individuals must meet their continuing requirements remains the same.

Copies of certificates earned or other documentation from the training provider will suffice for reestablishing the continuing education requirement. If documentation is not available, proper attestation will be acceptable for records dated up to October 1, 1994. FDA will continue to accept a limited form of attestation for CME received after October 1, 1994 in certain cases. (see Attestation - Acceptable Uses for Personnel Requirements)

Questions
  1. Under FDA’s interim regulations, when personnel were found deficient for not having at least 15 continuing medical education (CME) credits or units in the previous 36 months, they were given up to 90 days to obtain this training while continuing to work at a mammography facility without direct supervision. Will this 90-day period be continued under FDA’s final regulations?