Radiation-Emitting Products

We have a mammography unit that is used solely for interventional mammographic procedures. The unit is not MQSA certified. During the course of these interventional procedures, we take mammographic images. Because our unit is not MQSA certified, what restrictions exist on the mammographic images we may perform during such procedures?

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Because interventional mammography is currently excluded from regulation, units that are used solely for interventional procedures do not have to be MQSA certified. However, these uncertified units must not be used to perform conventional mammographic examinations. Uncertified units may be used to produce mammographic images only if they meet all of the following conditions:

  1. The mammographic images obtained are an integral part of an interventional procedure.
  2. Facilities must not bill separately for these mammographic images. They must bill only for the interventional procedure.
  3. If the mammographic images obtained as part of the interventional procedure result in the cancellation of the procedure (e.g. lesion or calcifications no longer seen, calcifications are determined to be in the skin), the facility must not report nor bill the attempted procedure as a mammogram, but rather as a canceled procedure.
  4. If the procedure is canceled for reasons described in 3, FDA strongly recommends that the findings (or absence of findings) be confirmed by an immediate follow-up study performed on an MQSA certified unit.

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Page Last Updated: 08/12/2014
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