FDA 510(k) Exemptions for Class II Devices in 2026: Which Product Codes Are Affected and What Manufacturers Must Do

Why the FDA Is Exempting More Class II Devices from 510(k)

Since the 21st Century Cures Act was signed in December 2016, the FDA has been required to periodically publish lists of Class II devices that no longer need premarket notification. The logic is straightforward: if a device type has a long safety track record, well-understood technology, and a low adverse event profile, requiring manufacturers to submit a 510(k) every time they enter the market creates regulatory burden without meaningful public health benefit.

In 2026, the FDA has published two significant Federal Register notices advancing this agenda. Together, they affect hundreds of product codes across nearly every device classification panel — from cardiovascular accessories to dental products, surgical instruments, and general hospital supplies.

For manufacturers, the stakes are real. A device exempted from 510(k) can go to market faster, at lower cost, and with less documentation overhead. But the exemptions come with important limitations, and misunderstanding them can lead to compliance gaps.

The Two 2026 Federal Register Notices

Notice 1: Request for Comments — Broad Class II Device Exemptions (February 6, 2026)

Published on February 6, 2026 (Docket FDA-2026-N-0232), this notice announced the FDA's intent to exempt certain Class II devices from premarket notification requirements and requested public comments. This action built on the agency's earlier work under the Cures Act, including the landmark 2017 final list that exempted hundreds of product codes.

The February 2026 notice identifies devices where the FDA preliminarily concluded that 510(k) is no longer necessary to provide reasonable assurance of safety and effectiveness. Comments on this notice were accepted through the docket, and the FDA will issue a final determination after reviewing stakeholder input.

Notice 2: Request for Comments on Additional Exemptions (May 1, 2026)

Published on May 1, 2026 (91 FR 23427, Docket FDA-2026-N-4268), this notice proposes expanding 510(k) exemptions to additional Class II devices. The FDA is soliciting public comments through June 30, 2026.

This second notice covers additional device types that the FDA is proposing for exemption through a separate docket. The agency is specifically requesting feedback on whether the proposed exemptions are appropriate and whether additional limitations should apply.

What Types of Devices Are Affected

The proposed and finalized exemptions span a wide range of device categories. Examples of product codes covered include:

The full list of affected product codes is available in Tables 1 and 2 of the respective Federal Register notices. Manufacturers should search the FDA's Product Classification Database to determine if their specific device is included.

FDA's Exemption Criteria

The FDA evaluates Class II devices for 510(k) exemption against a consistent set of factors, originally described in the January 21, 1998 Federal Register notice and the February 1998 guidance document "Procedures for Class II Device Exemptions from Premarket Notification." The four key factors are:

1. No significant history of false or misleading claims or risks from inherent device characteristics. The FDA reviews adverse event data, recall history, and Medical Device Report (MDR) filings for the device type. If the data shows a clean safety profile over an extended period, this factor is satisfied.

2. Characteristics necessary for safe and effective performance are well established. This means the device's design, materials, and performance parameters are standardized across the industry and well understood by both manufacturers and the FDA.

3. Changes that could affect safety or effectiveness are either readily detectable by users before causing harm, or would not materially increase risk. The FDA considers whether device modifications would be obvious to clinicians or patients, or whether the device is simple enough that changes carry minimal risk.

4. Changes would not result in a fundamental alteration of the device's intended use. If modifications would change what the device is supposed to do, a 510(k) is still needed regardless of exemption status.

Critical Limitations: When You Still Need a 510(k)

An exemption does not mean carte blanche. The Cures Act and the FDA's implementing regulations establish clear boundaries:

General Limitations

All exempt devices remain subject to the general limitations in 21 CFR 862.9 through 892.9. A manufacturer must still submit a 510(k) before marketing if:

• The device is intended for a use different from the original cleared or classified intended use
• The device uses a different fundamental technology than what was reviewed in establishing classification
• The device is a combination product that includes a drug or biologic component
• The device is intended for a new patient population not covered by the classification

Partial Limitations

Some exemptions include product-code-specific partial limitations. For example, the electronic stethoscope (DQD) exemption is limited to devices that:

1. Do not include diagnostic algorithms (e.g., murmur detection, arrhythmia detection)
2. Do not produce diagnostic outputs
3. Are solely intended for sound amplification, filtering, and transferring sounds

A manufacturer of an AI-powered digital stethoscope with automated murmur detection would not qualify for this exemption and would still need a 510(k) — or potentially a De Novo classification if the algorithm represents a new intended use.

Other Regulatory Requirements Still Apply

Exemption from 510(k) does not exempt the manufacturer from:

• Registration and listing (21 CFR Part 807)
• Quality Management System Regulation (21 CFR Part 820 / QMSR, effective February 2, 2026)
• Labeling requirements (21 CFR Part 801)
• Medical Device Reporting (21 CFR Part 803)
• UDI requirements (21 CFR Part 830)
• Pre-market approval (PMA) if the device is Class III for other reasons

Practical Steps for Manufacturers

Step 1: Check Your Product Code

Search the FDA's Product Classification Database using your device name or product code. The database will indicate whether your device type is currently exempt from 510(k) requirements.

Step 2: Review the Specific Limitations

Even if your product code is listed as exempt, read the classification regulation and any partial limitations carefully. If your device incorporates features not covered by the exemption — such as AI algorithms, wireless connectivity, or new diagnostic capabilities — you may still need a 510(k).

Step 3: Confirm You Meet All Other Requirements

Exemption from 510(k) does not mean exemption from the QMSR. Your manufacturing facility must still comply with 21 CFR Part 820 (as amended by QMSR), including ISO 13485:2016 requirements. You must still register your establishment and list your device.

Step 4: Document Your Rationale

If you are marketing a device under a 510(k) exemption, maintain internal documentation explaining why the exemption applies. This should include:

• The product code and classification regulation
• The Federal Register notice establishing the exemption
• An analysis of why your specific device falls within the scope of the exemption
• An assessment of whether any partial limitations apply

This documentation will be important during FDA inspections, particularly under the new QMSR inspection approach.

Step 5: Submit Comments if Applicable

If the May 2026 proposal includes product codes relevant to your business, consider submitting comments through Regulations.gov (Docket FDA-2026-N-4268) before the June 30, 2026 deadline. The FDA specifically requests feedback on whether the proposed exemptions are appropriate and whether additional limitations should apply.

Impact on the Regulatory Landscape

The expansion of 510(k) exemptions reflects a broader FDA strategy under CDRH to focus regulatory resources on higher-risk devices and emerging technologies. The agency has signaled that it intends to continue identifying Class II device types appropriate for exemption, particularly where:

• The device type has been on the market for decades with a strong safety record
• Special controls have been established that adequately mitigate residual risks
• The technology is mature and well-characterized in the literature

For the medical device industry, this trend means that companies producing established, low-to-moderate risk devices may face progressively less premarket burden — freeing resources for post-market surveillance, quality system improvements, and innovation in higher-risk product categories.

At the same time, the FDA has shown it will not hesitate to withdraw proposed exemptions when evidence doesn't support them. In 2021, HHS withdrew a proposal to exempt 84 device types after determining the notice contained errors and that many of the targeted product codes — particularly software-based devices cleared through De Novo — did not meet the well-established-technology criterion.

Key Takeaways

• The FDA published two Federal Register notices in 2026 affecting hundreds of Class II product codes for 510(k) exemption
• The February 2026 notice finalized exemptions for certain devices; the May 2026 notice proposes additional exemptions with a comment deadline of June 30, 2026
• Exemptions are subject to general and partial limitations — manufacturers must carefully evaluate whether their specific device qualifies
• Even exempt devices must comply with QMSR, registration and listing, labeling, MDR, and UDI requirements
• Manufacturers should verify exemption status through the FDA Product Classification Database and maintain documentation supporting their exemption rationale