Six questions, two minutes, scored against the cybersecurity deficiencies FDA issues most. Built from 1,000+ submissions of review experience.
The FDA readiness check is a free two minute diagnostic. Six yes or no questions, scored against the cybersecurity deficiencies FDA issues most, built from 1,000+ submissions of review experience. Answer all six and the result appears on the page once you enter your details.
The six cover whether FDA rejected or questioned a justification for an unfixed pentest finding, whether you could produce test cases per interface such as USB, Wi-Fi and Bluetooth, whether a postmarket vulnerability management plan is documented, whether testing history covered all in scope components, whether the postmarket plan includes recurring annual penetration testing, and whether a fix shipped without on-device proof.
Zero flagged answers is a clean sheet, if the evidence holds. The remaining risk is proof: every vulnerability you dismissed still needs a test case and a written rationale behind it. Nothing flagged is not the same thing as having something to show a reviewer.
Three or more puts a submission in the range that routinely draws major deficiency letters. One or two still cost review cycles on a ship date. All six questions trace back to the same cause, which is why continuous, evidenced testing closes all of them together.
The result links straight into the FDA deficiency list, which takes each of these deficiencies in turn, quotes the FDA language behind it, and shows what closes it. The readiness check tells you which ones you would draw. The list tells you what the answer looks like.