Stratigos Oracle

Medical device cybersecurity questions, answered

Ask in your own words. Every answer is one we wrote and checked, with its sources and the date a person last reviewed it.

Full questions match better than keywords, for example: does FDA require penetration testing for a 510(k)?
Get the answer for your case

The question alone gets the general answer. Say who it is for and what changes it, and you get the specific one; the results say which details they used.

Device type, pathway (510(k), PMA, De Novo), stage, and the decision in front of you. The situation, not the person: no names, companies, or contact details.

Asking records what you type, the answers suggested, and the next step you pick, under an anonymous session, so we can see what people come here to find. Nothing that identifies you is asked for, and anything resembling contact details is removed before storage. The privacy page has the rest.

About these answers

How the answers are written

Each answer is one question, answered by Stratigos and checked against the current FDA premarket cybersecurity guidance (the edition issued February 2, 2026) and the sources it lists. Your words are matched against the questions each one covers; nothing is generated by a model. Every answer carries one of three labels for how firm it is.

If the finder does not have your answer, ask it through the contact form. A person replies within one business day, and questions we hear more than once become answers here.

The guidance says so
The text of the guidance states it directly.
Reviewers expect this in practice
The guidance does not say it in so many words, but reviewers ask for it.
Our recommendation
Neither requires it, and the answer says why we advise it.