Mammography

Mammography means radiography of the breast, but, for the purposes of this part, does not include:
(1) Radiography of the breast performed during invasive interventions for localization or biopsy procedures; or
(2) Radiography of the breast performed with an investigational mammography device as part of a scientific study conducted in accordance with FDA's investigational device exemption regulations in part 812 of this chapter.

Source

21 CFR § 900.2

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Scoping language

The following definitions apply to subparts A, B, and C of this part:

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