> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# AdvaMed on Digital Breast Tomosynthesis Reclassification
- URL: https://www.fdaweb.com/advamed-on-digital-breast-tomosynthesis-reclassification/
- Published: 2026-11-12T21:09:19.000Z
- Updated: 2026-11-12T21:09:19.000Z
- Author: David McFarland
- Tags: Devices

AdvaMed says it is not taking a position on an FDA proposal to reclassify digital breast tomosynthesis systems from Class 3 into Class 2, but does have implementation concerns if the reclassification is approved. In its comment [letter](https://downloads.regulations.gov/FDA-2026-N-7630-0031/attachment%5F1.pdf?ref=fdaweb.com), the trade group says, “If FDA finalizes the proposed order, a clear, predictable, and appropriately phased transition will be essential to avoid unnecessary duplication, preserve regulatory continuity, and support consistent application of the new special controls.”

AdvaMed recommends that FDA:

- establish clear transition provisions for approved DBT systems and pending PMAs and PMA supplements, including recognition of previously approved PMA devices as predicates under the new Class 2 framework;
- make DBT-specific implementation guidance that explains the evidence, testing, comparator, and reader-qualification expectations associated with the special controls;
- publish draft implementation guidance sufficiently in advance of the final order and provide an adequate implementation period;
- apply evidence expectations proportionately to the nature and impact of a device modification and permit manufacturers to leverage prior evidence and targeted testing when scientifically justified;
- clarify that appropriate predicate devices for DBT 510(k) submissions are other legally marketed DBT systems; and
- clarify the regulatory treatment of accessories and auxiliary features under the reclassified DBT framework.