Headed to FDA with an AI-enabled device? Here is what to test, and what to keep monitoring, so the cybersecurity section of the submission holds up.
Tell us where to send it and the PDF opens on this page. Once, not every time.
The premarket position in one picture: the pipeline environment first, then every attack surface, every test tied to a named FDA threat.
Section 524B as the hard requirement, the January 2025 draft guidance as direction, and the seven threats Section XII names, read by the attack surface each one lives on.
Infrastructure first. Thirty-seven hands-on technical tests across six attack surfaces, listed in full, and five bounded adversarial exercises with the access each one needs.
The digital twin extended into the pipeline, CVSSv3 and CVSSv4 ratings on the MDDT-qualified rubric, a VEX-aligned lifecycle with CISA justifications, living reports and one threat-mapped report.
Two halves: the cybersecurity program FDA expects of any cyber device, and the data lifecycle IEC PAS 63621:2026 describes. Why the second depends on controls the first has to keep testing.
What to have ready so access does not become the schedule: the pipeline architecture, test access, the device reachable, prerequisites for the exercises, and the data record.
Premarket and postmarket, one page each, written so a regulatory lead can hand it to engineering and get a yes or a no on every line.
The paper is written to be handed across those desks without translation.
Who has to scope an AI-enabled engagement and answer for what was and was not tested.
Who has to place the seven AI-specific risks inside the 524B cybersecurity record and defend the evidence.
Who own the pipeline, will be asked to open it up, and inherit the model and its data record after clearance.
The premarket test plan and the postmarket surveillance method are on the ELTON site in full, with the visuals from the paper.
What is in the whitepaper?
ELTON's position on testing an AI-enabled medical device for FDA review: what the January 2025 draft guidance expects, the seven named threats and where they land, the premarket test plan (a pipeline environment pentest, thirty-seven technical tests and five bounded adversarial exercises), how findings are rated and dispositioned, and how postmarket surveillance works under IEC PAS 63621:2026. Twelve pages, with a checklist.
Who is it for?
Product security and cybersecurity leads at manufacturers with an AI-enabled device heading to review or already in the field, regulatory affairs teams placing AI-specific risks in a 524B record, ML engineering leaders who own the pipeline, and quality and postmarket teams who inherit the model after clearance.
Is it a product brochure?
No. It is the method, written so a reviewer or an engineer can follow it. ELTON is named where it describes what ELTON does; the test plan and the IEC clauses stand on their own.
Do I have to fill in the form?
Once. The form opens the download on this browser, and you will also get MedDevice AI Security Weekly, our newsletter on AI vulnerability discovery and FDA cybersecurity. Unsubscribe anytime.