Commercialization
Label Claims
In one line
Statements about a medical device's purpose, performance or benefits, subject to applicable labeling and intended-use requirements.
Definition
Label claims are statements in medical device labeling describing intended use, indications, performance or benefits. Their regulatory significance depends on the device, evidence and applicable pathway. Not every device or individual labeling statement has been reviewed and cleared or approved by FDA.
Claims must be assessed against applicable labeling requirements and, where required, the device's clearance, approval or other authorization. Advertising and related circumstances can also be evidence of intended use under 21 CFR 801.4. A device exempt from premarket notification is not exempt from all labeling obligations, and a claim should not imply FDA endorsement that the device does not have.
Why it matters
Review a label claim as a specific statement, not just a slogan. Identify the proposed purpose, patient population, user, use environment, endpoint and any operating conditions or limitations. Compare that statement with intended use, indications for use and the device's applicable authorization or exemption.
For a performance statement such as 'detects a condition earlier,' ask: earlier than what comparator, in which population, using which endpoint and under which conditions? A bench result does not automatically demonstrate a clinical benefit. Keep the evidence, limitations and wording together in a claims review so the statement does not promise more than the study supports.
Review the instructions for use, packaging, website, sales materials and demonstrations together for consistent messaging. Regulatory, quality, clinical and commercial teams can maintain a claim-to-evidence record and escalate proposed changes for the applicable intended-use and submission analysis. This is an illustrative review method, not a determination that a particular claim is lawful.
Common pitfalls
- •Treating all claims as individually FDA-approved.
- •Using a performance result from one population to promise benefit in a different population.
- •Leaving a comparator, endpoint or important limitation out of a benefit claim.
- •Allowing advertising and instructions for use to describe different intended purposes.
- •Assuming an exemption from premarket notification removes labeling obligations.
Sources
- AdvaMed Code of Ethics · AdvaMed
- AHRMM - Healthcare Supply Chain · AHRMM
- Device Labeling · FDA
- 21 CFR 801.4, meaning of intended uses · US official source