FDA proposes changing how digital breast tomosynthesis machines are regulated
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Table of Contents
The Food and Drug Administration (FDA) is proposing to change the regulatory category for digital breast tomosynthesis (DBT) systems. These are medical imaging devices used in mammography to create 3D images of breast tissue.
Why it matters: This is primarily an administrative change that would likely make it faster and less expensive for manufacturers to bring new digital breast tomosynthesis machines to market by reducing the level of regulatory scrutiny required before sale.
Who it affects
- Medical device manufacturers specializing in breast imaging technology
This is a proposed rule from the Food and Drug Administration; readers should consult the Federal Register for full details before taking action.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document