FDA Proposed Reclassification of Tuberculosis Immune Tests from Class III to Class II Devices
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
The FDA is proposing to reclassify two categories of medical devices used to diagnose Mycobacterium tuberculosis (TB) infection: cell-mediated immunity tests (product code NCD) and enzyme-linked immunospot (ELISpot) tests (product code OJN). Currently, both are classified as class III devices requiring Premarket Approval (PMA), the most stringent regulatory pathway. The proposal would move them to class II, requiring only Premarket Notification (510(k)) and compliance with special controls. The reclassification reflects FDA's determination that class II controls — including special controls such as performance standards, labeling requirements, and post-market surveillance — are sufficient to provide reasonable assurance of safety and effectiveness for these diagnostic devices. This is a less burdensome regulatory pathway that could lower barriers for manufacturers seeking to bring new TB diagnostic tools to market. As part of this proposal, FDA is also introducing a new device classification regulation specific to these TB immune response tests, codifying the special controls that manufacturers must meet. The proposal is open for public comment before any final rule is issued.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- TB cell-mediated immunity tests (product code NCD) reclassified from class III (PMA required) to class II (510(k) required)
- TB ELISpot tests (product code OJN) reclassified from class III (PMA required) to class II (510(k) required)
- New device classification regulation introduced specifically for TB immune response tests
+ 3 more changes with Pro
Obligations
What this law requires
Manufacturers of Mycobacterium tuberculosis cell-mediated immunity tests (product code NCD) must submit a Premarket Notification (510(k)) before marketing the device
Manufacturers of Mycobacterium tuberculosis ELISpot tests (product code OJN) must submit a Premarket Notification (510(k)) before marketing the device
Manufacturers must comply with special controls established by FDA for TB immune response tests, including performance standards requirements
Manufacturers must comply with labeling requirements specified in the special controls for TB immune response tests
Manufacturers must establish and maintain post-market surveillance programs as required by the special controls