FDA 510(k) Exemptions for Unclassified Devices: June 2026 Guidance Update

Why the FDA Is Exempting More Unclassified Devices

On June 5, 2026, the FDA published an updated guidance document titled "Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements" in the Federal Register (FR Doc. 2026-11303). The update adds five new product codes to the list of unclassified devices the agency intends to exempt from 510(k) premarket notification requirements, bringing the total to 13 product codes across seven medical specialty panels.

This is the first update to the guidance since June 2019 and reflects the FDA's ongoing effort — mandated by the Medical Device User Fee Amendments of 2012 (MDUFA) commitment letter — to propose exemptions for low-risk medical devices where premarket notification is no longer necessary to provide reasonable assurance of safety and effectiveness.

For manufacturers of the affected device types, the practical impact is immediate: the FDA has implemented the guidance without prior public comment and states that it does not intend to enforce 510(k) requirements for the identified devices during the interim period before a formal exemption rule is finalized. This means manufacturers can market these devices without submitting a 510(k), provided they comply with all other applicable regulatory requirements.

What Changed in the June 2026 Update

The Five New Product Codes

The June 2026 update adds five product codes that were independently reviewed by FDA advisory panels and recommended for classification into Class I or Class II. The FDA assessed each device type and concluded that the available information supports exemption from premarket notification.

These five join the eight product codes already included in the prior versions of the guidance (2015 original, 2019 update).

Complete List of 13 Exempt Product Codes

The updated guidance now covers the following product codes across seven specialty panels:

Ear, Nose, and Throat Devices:

• KGA – Hearing Protector, Insert
• KGB – Hearing Protector, Circumaural
• LQA – Speech Training Aid, Hearing Impairment (AC-powered)
• LQB – Speech Training Aid, Hearing Impairment (Battery-powered)

Gastroenterology and Urology Devices:

• LRL – Cushion, Hemorrhoid

General and Plastic Surgical Devices:

• LKB – Pad, Alcohol, Device Disinfectant
• MQZ – Prosthesis, Nail (new in June 2026)

Obstetrical and Gynecological Devices:

• LHD – Device, Fertility Diagnostic, Proceptive

Physical Medicine Devices:

• LDK – Device, Sensing, Optical Contour (new in June 2026)
• LZW – Monitor, Spine Curvature

Neurological Devices:

• MVV – Device, Acupressure (new in June 2026)

Toxicology Devices:

• MIG – Strip, Test Isoniazid (new in June 2026)

Ophthalmic Devices:

• LXQ – Cup, Eye (new in June 2026)

How the Exemption Works in Practice

Interim Enforcement Discretion

The guidance does not create a formal regulatory exemption — that requires rulemaking. Instead, the FDA announces its intent to exempt these devices and states that it does not intend to enforce compliance with 510(k) requirements during the interim period. The agency does not expect manufacturers to submit 510(k)s for these devices.

This enforcement discretion approach means:

• Manufacturers may market these devices without first obtaining 510(k) clearance
• The FDA reserves the right to begin enforcing 510(k) requirements if safety concerns emerge
• A future final rule would codify the exemption permanently

What This Exemption Does Not Cover

The exemption from premarket notification is narrow. It applies only to the requirement to submit a 510(k) before marketing. It does not exempt manufacturers from other regulatory controls, including:

• Establishment registration and device listing (21 CFR Part 807)
• Labeling requirements (21 CFR Part 801)
• Quality Management System Regulation (QMSR) compliance (21 CFR Part 820)
• Medical Device Reporting (MDR) obligations (21 CFR Part 803)

Additionally, the exemption does not apply to combination products, including single-entity products containing an antimicrobial agent, that may fall within the listed product codes.

Limitations on Exemptions

Even when a product code is exempt, general limitations apply. Under 21 CFR 862.9 through 892.9, a manufacturer must still submit a premarket notification before introducing a device into commercial distribution when the device:

• Uses a different fundamental scientific technology than a legally marketed device in that generic type
• Has a different intended use than a legally marketed device in that generic type
• Is a device type for which the FDA has issued a regulation requiring a 510(k) for a specific technology, material, or feature

How This Fits Into the Broader 510(k) Exemption Landscape

The June 2026 unclassified device guidance is one of three parallel FDA tracks for 510(k) exemptions in 2026:

Track 1: Class II Device Exemptions (February and May 2026)

The FDA published two Federal Register notices proposing 510(k) exemptions for large numbers of classified Class II devices:

• February 6, 2026 (Docket FDA-2026-N-0232): The first notice covering a broad set of Class II product codes, now closed for comments.
• May 1, 2026 (91 FR 23427, Docket FDA-2026-N-4268): An additional set of Class II devices proposed for exemption, with comments accepted through June 30, 2026.

These Class II exemption notices affect hundreds of product codes and are separate from the unclassified device guidance. The classified devices have already been through the formal classification process and have established regulation numbers.

Track 2: Unclassified Device Exemptions (June 2026)

The guidance covered in this article targets preamendment devices that have not yet been formally classified. These devices were on the market before the Medical Device Amendments of 1976 and have not been assigned to Class I, II, or III through regulation. The FDA advisory panels have reviewed these devices and recommended classification, but the formal rulemaking to assign classes has not been completed.

Track 3: Statutory Class I Exemptions

Most Class I devices are already exempt from 510(k) requirements by statute under Section 510(l)(1) of the FD&C Act, subject to certain limitations. The FDA maintains a searchable database of 510(k) and GMP exemptions on its website.

Why This Matters for Manufacturers

Cost and Time Savings

A standard 510(k) submission involves significant resources. The FY 2026 standard 510(k) user fee is $26,067 for establishments with gross receipts exceeding $5 million. Beyond the fee, preparation costs — including testing, documentation, and regulatory consulting — typically range from $50,000 to $150,000 depending on the device type. Eliminating the 510(k) requirement for these devices removes both the direct and indirect costs.

Faster Time to Market

Without the 510(k) requirement, manufacturers can move from product development to commercial distribution without waiting for FDA clearance. The average 510(k) review time in recent years has been approximately 100–180 days for devices that receive additional information requests. For exempt devices, this entire timeline is eliminated.

Ongoing Compliance Obligations

The exemption does not create a regulatory vacuum. Manufacturers must still maintain QMSR compliance, register their establishments, list their devices, follow labeling requirements, and report adverse events through the MDR system. The QMSR — effective February 2, 2026 — incorporates ISO 13485 by reference, meaning that even exempt device manufacturers must maintain a quality management system consistent with the standard.

How to Determine If Your Device Qualifies

Step 1: Identify Your Product Code

Confirm your device's three-letter product code through the FDA's Product Classification Database. The product code is assigned based on the device's intended use and technology.

Step 2: Check the Exemption Guidance

Compare your product code against the list in Section IV of the guidance document. The guidance is available on the FDA's website at the guidance document search page (Docket FDA-2014-D-0967).

Step 3: Verify No Limitations Apply

Review the applicable limitation sections in 21 CFR (the .9 sections of each classification regulation part). Even if your product code appears on the exemption list, limitations related to technology, intended use, or specific features may require a 510(k).

Step 4: Confirm Registration and Listing

Ensure your establishment is registered and your device is listed with the FDA under 21 CFR Part 807. Even exempt devices must be listed.

Step 5: Maintain QMSR Compliance

Verify your quality management system meets QMSR requirements under 21 CFR Part 820. For exempt devices, this includes design controls (if applicable), document control, CAPA, and production controls.

Relationship to the MDUFA Commitment

The June 2026 guidance fulfills a specific commitment the FDA made during the MDUFA reauthorization process. In the MDUFA commitment letter associated with the 2012 reauthorization, the FDA committed to proposing exemptions for certain low-risk medical devices from premarket notification requirements. The agency has been incrementally fulfilling this commitment through the 2015 initial guidance, the 2019 update, and now the June 2026 update.

The 2019 update added four product codes (LKB, LRL, LHD, LZW). The June 2026 update adds five more (LDK, MVV, MQZ, MIG, LXQ), reflecting the panel review process for additional unclassified devices that had been pending classification.

Looking Ahead

The FDA continues to review additional unclassified devices for potential exemption. The June 2026 update suggests the agency is actively working through the backlog of preamendment unclassified devices that panel reviews have recommended for Class I or II classification.

Separately, the Class II exemption rulemaking track — with the February and May 2026 Federal Register notices — may ultimately exempt hundreds more classified device types from 510(k) requirements. Manufacturers should monitor the relevant dockets (FDA-2026-N-0232 and FDA-2026-N-4268) for final determinations.

Key Takeaways

• The June 5, 2026 guidance adds five product codes (LDK, MVV, MQZ, MIG, LXQ) to the 510(k) exemption list for unclassified devices, bringing the total to 13
• The FDA has implemented the guidance without prior comment and does not intend to enforce 510(k) requirements for the identified devices
• The exemption applies only to premarket notification — not to QMSR, labeling, registration, listing, or MDR requirements
• Combination products within the listed product codes are not covered by the exemption
• The guidance is open for comments through Docket FDA-2014-D-0967, though it is effective immediately
• Manufacturers should verify their product code, check for limitations, and ensure full compliance with remaining regulatory controls before relying on the exemption