Separate device pathways from registration

Understand the different decisions

A 510(k) submission generally addresses substantial equivalence to a legally marketed predicate and results in clearance when accepted by FDA. De Novo is a classification route for certain novel low-to-moderate-risk devices. PMA involves approval for devices requiring that pathway. A documented exemption concerns a particular requirement and is not a waiver of every other duty.

Do not infer the route solely from Class I, II or III. Check the classification regulation, product code, exemption limitations, special controls and the actual intended use. Distinguish a third-party certificate, a supplier statement and an FDA decision. The free pre-check records whether you have pathway evidence; it does not adjudicate its sufficiency.

Compare the device with the decision record

Match the legal manufacturer, model family, indication, intended users, technology, accessories and labeling against the record relied on. Keep the decision letter and applicable labeling or summary, not just a database screenshot. For an exemption, identify the regulation, exact limitation and facts supporting the conclusion. Unknown evidence remains a review item.

For example, adding a new disease indication or a different operating principle to an existing device may require a separate change assessment. The old authorization number cannot simply be copied to new marketing material. Record the change, its risk implications and the documented pathway decision before implementing the revised label or sales claim.

Use careful wording in public claims

Use the regulatory term that actually matches the record: cleared, authorized, approved or exempt where supported. Avoid generic FDA-approved wording for registration, listing or a 510(k) clearance. A search result for a similarly named device is not proof that your product is the subject of the decision.

Keep evidence and decisions separate

Keep the original evidence and the released device version together. When a source or fact is uncertain, record the open question instead of converting it into a pass. Official database references and this checklist do not substitute for a device-specific decision.

Official starting points for this topic

• FDA premarket notification 510(k)
• FDA overview of device regulation
• FDA classify your medical device

FDA page topics were checked on October 7, 2026. Linked regulations and database records still need product-specific applicability review; public links do not establish that a device is authorized.

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