Disclaimers and advertising disclosure

Not professional advice

Content on this site, and the output of its free tools, is general information. It is not regulatory, legal, clinical, medical, or engineering advice, and using the site does not create a client relationship. Decisions about a regulatory pathway, a submission, a test plan, or a design should be made with a qualified professional who has reviewed your specific device and situation, and — where it matters — confirmed with FDA or your notified body.

No device performance claims

This site describes engineering and regulatory services. Nothing here is a claim about the safety, effectiveness, or clinical or technical performance of any medical device, ours or anyone else’s.

Free tools and public data

The tools summarize public sources such as FDA’s openFDA, the Global UDI Database, and PubMed. Those sources can be incomplete, delayed, or wrong, and a summary of them is no better. Figures such as review times or event counts describe the past records they were computed from, not what will happen to your submission. Each tool shows its own data and limitations block next to its results; read it before relying on a number. We are not affiliated with, and not endorsed by, FDA or any other agency whose data the tools use.

AI-assisted output

Some tools and services use AI models. AI output can be wrong in confident-sounding ways, and should be checked by a person before it is used in a regulated record.

Targets and examples

Where a page gives a timeline or a figure for our own work, it is either a requirement from a named standard, a publicly verifiable fact, or a design target labelled as such — not a guarantee of results. Examples and illustrations are hypothetical unless stated otherwise.

Advertising disclosure

• We advertise. We pay for ads on LinkedIn to bring people to this site. If you arrived from one, the link may carry a campaign tag so we can count which ads are useful, as described in the privacy policy.
• This site carries no advertising. We do not show third-party ads, do not use affiliate links, and are not paid to mention any product, vendor, or tool.
• Nothing here is sponsored. When we mention a standard, a database, or a vendor, it is because it is relevant, not because anyone paid for the mention. If that ever changes, the content will say so where it appears.
• No advertising pixels. This site does not load LinkedIn’s or anyone else’s tracking pixel.
• We sell services. Our free tools and articles exist in part to show how we work. Where a page invites you to book a scoping review, that is 10xAnd marketing its own services.

Questions

See also our terms of use. Questions can be sent through any form on this site.