Prepare a medical device label for U.S. review

A workable review order

Record the intended use and indication before selecting a class. Identify the body-contact materials, operating principle, patient population, user environment and accessories. Then locate the applicable classification regulation and product code. Similar appearance or a marketplace category is insufficient; unresolved classification should remain unknown in the pre-check.

Review the marketing pathway separately from establishment registration and device listing. Compare every labeling claim with the actual authorized or documented exempt scope. Next review manufacturer or distributor identification, applicable quantity or contents statements, instructions, limitations, contraindications, warnings and UDI duties. Class I does not automatically mean every duty is exempt.

Build one versioned device packet

Keep the device specification, model and accessory list, classification rationale, product-code source, pathway evidence and released labeling together. Include final-size package proofs, device marking photographs, the current instructions for use, translations, risk-control records and UDI assignment data where applicable. Identify who released each artifact and the date.

For example, changing a home-use monitor from a professional-use version may change the intended user, instructions, use environment and evidence needs. Copying the old label and changing only the brand is not an adequate review. Reopen the affected classification, pathway, usability and labeling decisions before releasing the new version.

What this free pre-check does

Use the checklist below to organize the evidence, or enter known device facts in the product pre-check. FDA product-code resources provide references only; this public form records the class and code you declare without looking them up or verifying that your design fits that code. Published rule prompts highlight missing declarations and source gaps. They do not inspect a technical file or test performance.

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 device labeling
• 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.

Continue the device review