Review device claims in their full context

Inventory every claim-bearing surface

Collect package wording, instructions, product pages, ads, marketplace bullets, diagrams, before-and-after images and testimonials used by the business. Record the implied message as well as the literal sentence. Claims about diagnosis, treatment, accuracy, patient population or use environment can affect the intended-use assessment and required supporting evidence.

Compare each statement with the applicable device record and its actual scope. Match the same model, configuration, accessories, intended users and conditions. A performance result under one test condition does not establish every broader marketing statement. Keep the study, validation or other substantiation tied to the claim and released device version.

Keep regulatory wording precise

Distinguish 510(k) clearance, De Novo authorization, PMA approval, establishment registration and device listing. Do not convert registration or listing into an FDA-approved claim. For an exempt device, document the exact basis and limits instead of implying FDA reviewed its safety or effectiveness merely because it appears in a database.

For example, a cleared device with a limited indication may be advertised with a broader disease-treatment promise. The presence of a clearance number does not settle the new statement. Compare the claim with the decision record, assess the changed intended use and record the pathway and evidence review before publishing that wording.

Use the right tool for the task

Use this device cluster and the device checklist to organize questions. The public product pre-check can record your declarations and show published preparation prompts. Do not use the supplement claims checker to determine a device indication or assume that no flagged keyword means an acceptable claim. No tool here validates clinical evidence or grants marketing authorization.

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 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