> ## 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.

# Change Device Enforcement Guide: AdvaMedDx
- URL: https://www.fdaweb.com/change-device-enforcement-guide-advameddx/
- Published: 2024-07-10T12:00:00.000Z
- Updated: 2026-09-14T14:35:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157323

AdvaMedDx is calling for changes to an FDA draft guidance on the enforcement policy for certain in vitro diagnostic devices for immediate public health response in the absence of a declaration under Section 564\. The trade group [says](https://downloads.regulations.gov/FDA-2024-D-0083-0007/attachment%5F1.pdf?ref=fdaweb.com) the scope of the guidance should include all in vitro diagnostic manufacturers and not be limited to only laboratory manufacturers. It also says FDA should establish a mechanism for reaching out to proven developers to initiate development for in vitro diagnostics for an immediate public health response.