Review FDA device classification and product code

Start with intended use, not the seller category

Write the exact function, indication, intended patient and operator, anatomical site and use setting. Explain the technology, contact duration, accessories and whether the item is a finished device or a component. Compare those facts with the classification description and applicable regulation. A supplier code is a starting lead, not a decision.

The three classes broadly correspond to increasing regulatory control, but class alone does not settle a submission route, exemption, special controls or labeling duties. Review the regulation and code together, including limitations that can invalidate an exemption. If multiple descriptions seem plausible, record the alternatives rather than choosing the lowest class.

Use the reference lookup safely

In the free product form, select Medical Devices and enter a known three-letter FDA product code. Leave the class unknown if it is unresolved. The form records your declarations without a public lookup. Use FDA classification resources to review the source record; no result, an unavailable source or an unusual class must remain unresolved. A database reference does not authorize a pathway.

For example, a device described as a wellness accessory online may still have a medical intended use when the manual promises diagnosis or treatment. Compare the complete claims inventory, not only the name. Keep the retrieved record, retrieval date, classification rationale and reviewer decision with the matching device version; recheck after technology or intended-use changes.

Resolve uncertainty before relying on an exemption

Investigate differences in indication, design and technological characteristics rather than assuming a similar competitor establishes your classification. When the public description does not resolve the boundary, use the appropriate FDA classification resources or formal inquiry route. This site organizes questions and evidence; it cannot supply a binding classification 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 classify your medical device
• FDA overview of device regulation

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.

Continue the device review