FDA Proposes Reclassifying TB Immunity Tests to Class II

Regulatory Citation: Federal Register Vol. 91, Document 2026-06064 (Published March 30, 2026) Affected Product Codes: NCD (Mycobacterium tuberculosis cell-mediated immunity tests) and OJN (Mycobacterium tuberculosis cell-mediated immune response enzyme-linked immunospot tests)

In a significant regulatory move published on March 30, 2026, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would reclassify two categories of Mycobacterium tuberculosis (MTB) diagnostic devices from Class III (Premarket Approval/PMA) to Class II (Special Controls/510(k)). For manufacturers currently holding or pursuing PMA approvals — or for those who have been sitting on the sidelines waiting for a clearer regulatory pathway — this proposal is a potential game-changer.

The lesson here is straightforward: proactive engagement with the rulemaking process now can save your organization months of regulatory delay and hundreds of thousands of dollars in PMA costs later. This article breaks down exactly what FDA is proposing, why it matters, and how manufacturers of TB diagnostic devices should respond.

What Is FDA Actually Proposing?

The proposed rule, published in the Federal Register under Docket No. FDA-2026-06064, covers two specific device classifications:

• Product Code NCD — Mycobacterium tuberculosis cell-mediated immunity (CMI) tests (e.g., interferon-gamma release assays, or IGRAs)
• Product Code OJN — Mycobacterium tuberculosis cell-mediated immune response enzyme-linked immunospot (ELISpot) tests

Both device types are currently postamendments Class III devices, meaning any manufacturer seeking to market them must submit and receive approval of a full Premarket Approval (PMA) application — the most rigorous and resource-intensive FDA marketing pathway. FDA is proposing to move these devices into Class II, where they would instead be subject to Premarket Notification (510(k)) requirements, with oversight provided through Special Controls rather than PMA-level review.

Critically, FDA is also proposing to exempt these devices from the 510(k) requirement under certain conditions, which could further streamline market access for qualifying manufacturers.

Why Is This Reclassification Significant?

The regulatory burden difference between Class III and Class II is enormous. Consider these benchmarks:

• A typical PMA application costs manufacturers between $500,000 and $1,000,000+ in preparation costs and takes an average of 180 days for FDA review — often longer with major deficiency letters.
• A 510(k) submission, by contrast, averages approximately $31,000 in FDA user fees (FY2026) and has a standard review clock of 90 days for traditional 510(k)s.
• According to FDA's own data, Class II device clearances through the 510(k) pathway represent approximately 80% of all medical device market authorizations in the United States.

Reclassifying NCD and OJN devices from Class III to Class II signals that FDA has concluded — based on accumulated safety and effectiveness data — that general controls and special controls are sufficient to provide reasonable assurance that these devices are safe and effective, without the need for PMA-level scrutiny.

This matters enormously for the tuberculosis diagnostics market. Tuberculosis remains the second leading infectious disease killer globally, with the World Health Organization (WHO) reporting 1.25 million TB deaths in 2023. Reducing regulatory barriers to bringing accurate, validated TB diagnostic tools to market has direct public health implications.

The Regulatory Framework: Class III to Class II — What Actually Changes?

Understanding this reclassification requires a clear view of the three-class device framework under 21 CFR Part 860 and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Role of Special Controls

When FDA reclassifies a device from Class III to Class II, it must establish Special Controls — device-specific requirements that mitigate the risks not addressed by general controls alone. For NCD and OJN devices, FDA is expected to define special controls addressing:

• Performance testing standards (analytical and clinical performance, including sensitivity, specificity, and reproducibility)
• Labeling requirements specific to TB diagnostic use, including intended use limitations (e.g., not to be used as a sole diagnostic)
• Postmarket surveillance requirements, potentially including real-world performance studies
• Cybersecurity or software validation requirements if applicable to device design

The final special controls will be codified in 21 CFR Part 866, which governs immunology and microbiology devices. Manufacturers should monitor the docket closely as FDA fleshes out these requirements in response to comments.

Who Is Directly Affected?

If your organization falls into any of the following categories, this proposed rule demands immediate attention:

Current PMA Holders (NCD/OJN Devices)

If you currently market a TB CMI test or ELISpot test under an approved PMA, reclassification means your device would transition to Class II oversight. You would no longer need to submit PMA supplements for many post-approval changes — instead, you may file 510(k)s for significant changes or rely on the special controls framework for minor modifications. This reduces your long-term regulatory maintenance burden substantially.

Companies With Pending PMA Applications

This is where the reclassification creates the most immediate strategic opportunity. If you have a PMA under review for an NCD or OJN device, the practical reality is that once a final rule is published, the applicable pathway shifts. Work with regulatory counsel now to understand your transition options.

New Market Entrants

Perhaps the biggest beneficiaries of this proposed change are companies that have been deterred from entering the TB diagnostics space due to the PMA requirement. A 510(k) pathway — particularly with potential exemptions — could open the door to new innovation in a high-need diagnostic category.

International Manufacturers Seeking U.S. Market Access

For CE-marked or WHO-prequalified TB diagnostic manufacturers outside the United States, the 510(k) pathway is generally more accessible than PMA. This reclassification could accelerate U.S. market entry timelines for established international products.

Key Dates and Deadlines You Cannot Miss

The Federal Register notice published March 30, 2026 initiates a formal public comment period. Here is the critical timeline you must track:

⚠️ Action Required: Submit written comments through regulations.gov referencing Docket No. FDA-2026-06064 before the comment period closes. This is your only formal opportunity to influence the final special controls, exemption criteria, and transition provisions.

Practical Compliance Guidance: What to Do Right Now

Drawing on my experience guiding 200+ clients through FDA regulatory transitions at Certify Consulting — with a 100% first-time audit pass rate — here is the practical action plan I recommend for manufacturers affected by this proposed rule.

Step 1: Confirm Your Device's Classification Status

Pull your device's 510(k) decision summary, PMA approval order, or De Novo authorization and confirm whether your product falls under product code NCD or OJN. If you are unsure, conduct a product code search on FDA's 510(k) database and confirm classification via 21 CFR 866.3950 or related subparts. This is your regulatory starting point.

Step 2: Assess Your Current Regulatory Documentation

Conduct a gap assessment of your existing technical file or PMA against likely Class II Special Controls requirements. Even though special controls have not yet been finalized, you can anticipate performance testing, labeling, and QMS requirements based on analogous Class II IVD reclassifications. Start building your 510(k)-ready documentation now.

Step 3: Submit a Comment to the Docket

Do not underestimate the value of participating in the notice-and-comment process. Manufacturers who engage directly with FDA during proposed rulemaking consistently achieve better outcomes — whether that means more favorable special controls, longer transition periods, or clarified exemption criteria. Prepare a data-driven comment that addresses your device's risk profile and performance record.

Step 4: Review Your Quality Management System for 510(k) Alignment

Your Quality Management System (QMS) under 21 CFR Part 820 (now harmonized with ISO 13485:2016) governs both PMA and 510(k) pathways — but the post-market change control processes differ significantly. Under Class II with special controls, your Design Change procedures (820.30/ISO 13485 clause 7.3.9) must clearly delineate what constitutes a significant change requiring a new 510(k) versus what can be managed internally. Update your SOPs accordingly.

Step 5: Monitor the Docket and Engage Regulatory Counsel

Assign a regulatory affairs owner to monitor the FDA docket for this rule. Key developments to watch include: - Publication of draft special controls language - FDA's response to significant comments - Final rule publication and effective date announcement - Any guidance documents FDA issues in parallel

For complex situations — particularly if you have an active PMA application or are a new market entrant — engaging a qualified regulatory consultant early is significantly more cost-effective than reactive remediation after a final rule is in place.

The Broader Context: FDA's IVD Reclassification Trend

This proposed reclassification does not exist in a vacuum. Over the past decade, FDA has consistently moved mature, well-characterized in vitro diagnostic (IVD) device categories from Class III to Class II as the evidence base for their safety and effectiveness matures. Notable precedents include reclassifications in:

• Hepatitis C antibody tests (reclassified from Class III to Class II)
• HIV diagnostic tests (various reclassifications over time)
• Influenza virus antigen detection systems

The TB CMI test reclassification follows this established pattern and reflects FDA's confidence in the clinical performance data accumulated from devices like the QuantiFERON-TB Gold Plus (Qiagen) and T-SPOT.TB (Oxford Immunotec), both of which have substantial real-world performance records supporting the safety and effectiveness of this device category.

FDA's reclassification of NCD and OJN devices represents a regulatory recognition that TB cell-mediated immunity testing technology has matured to a point where Class III controls are no longer necessary to ensure patient safety. This is a meaningful signal to the diagnostics industry about FDA's current risk assessment for this technology.

How Certify Consulting Can Help

At Certify Consulting, I have guided medical device manufacturers through dozens of reclassification transitions, 510(k) submissions, and QMS alignments. Whether you need help interpreting the proposed rule's impact on your specific product, drafting a substantive comment to the FDA docket, preparing a 510(k) submission strategy, or updating your QMS for Class II compliance, we provide full-service regulatory support with the technical depth and practical experience your timeline demands.

With 200+ clients served and a 100% first-time audit pass rate, we understand that regulatory transitions create both risk and opportunity. The manufacturers who act now — before the final rule is published — will be best positioned to capitalize on the reduced regulatory burden this reclassification offers.

👉 Learn more about our FDA regulatory consulting services at certify.consulting 👉 Explore our IVD and medical device compliance resources

Summary: Key Takeaways

• FDA published a proposed rule on March 30, 2026 (Federal Register Doc. 2026-06064) to reclassify MTB CMI tests (NCD) and ELISpot tests (OJN) from Class III (PMA) to Class II (510(k) with Special Controls).
• The reclassification would dramatically reduce regulatory burden for manufacturers — from PMA to 510(k), with possible exemptions.
• A public comment period is open — this is your window to shape the final special controls and transition provisions.
• Manufacturers should immediately assess their device classification status, conduct a documentation gap assessment, and engage regulatory counsel.
• The final rule is expected within 12–24 months of the comment period close, with a 30-day effective date trigger thereafter.

Last updated: 2026-04-03

Jared Clark, JD, MBA, PMP, CMQ-OE, CPGP, CFSQA, RAC is the Principal Consultant at Certify Consulting. With 8+ years of experience and 200+ clients served, Jared specializes in FDA medical device regulation, ISO 13485 certification, and IVD compliance. Visit certify.consulting for more.