Panel-recommended. Not yet classified.

A product code’s classification field holds one of three values almost everywhere in FDA’s device record — Class I, Class II, or Class III. A fourth value exists, and it is not a risk tier at all: unclassified, the status of a device type that was already on the market before the 1976 Medical Device Amendments created the classification system and that FDA’s original review panels simply never got to. An unclassified device type has no classification regulation — and until one exists, a 510(k) is still required to market it.

A decade of updates to the same guidance

FDA has worked through part of that backlog under a single guidance, docket FDA-2014-D-0967, titled Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements. The original version issued July 1, 2015, superseded within weeks by an August 14, 2015 revision; FDA updated it again on February 8, 2019, then again on June 14, 2019 to remove product codes that turned out to already be exempt for other reasons. On June 5, 2026, FDA published a fourth update — its first since 2019 — adding five more product codes its advisory panels have reviewed and recommended for Class I or Class II status. The list now runs to thirteen product codes. Proposing exemptions like these was itself a commitment FDA made in the negotiated MDUFA III commitment letter, part of the 2012 device-user-fee reauthorization, in which the agency agreed to identify low-risk device types for exemption from premarket notification.

What “intent to exempt” actually commits FDA to

The guidance states plainly why these thirteen product codes made the list: FDA believes each is well enough understood that a 510(k) is not needed to assure its safety and effectiveness, and the agency does not intend to enforce the premarket-notification requirement against them while that belief stands. That is a statement of present intent, not a rule. A classification regulation — the kind that actually moves a product code into Class I or Class II, in the CFR, through notice-and-comment rulemaking — is a separate, later act FDA has not taken for any of these thirteen codes. Until it does, the classification statute still governs, and the codes remain, on paper, unclassified.

A panel’s recommendation is a fact about what FDA plans to do. A classification regulation is a fact about what FDA has done. The guidance only ever promises the first one.

The practice

Read a classification lookup for one of these thirteen product codes today, and the device class field still returns unclassified — the June 2026 guidance changes FDA’s stated enforcement posture, not the codified record a database like this one, or openFDA’s own classification endpoint, actually reads. A firm holding one of these codes gets real, usable information from the guidance: FDA is not currently going to ask for a 510(k) it believes is unnecessary. What the firm does not get is a field anywhere that says so, and a guidance is exactly as durable as FDA’s next guidance revision — nothing here requires the notice-and-comment process a real classification regulation, or its reversal, would. This is regulatory intelligence and method, never regulatory advice about whether a specific unclassified product code is safe to rely on for a specific filing decision.