Vynix LLC (Omakyn) (Martin Gaspar Maciel)

Vynix LLC (Omakyn) submits the attached comment on Questions 24 and 25 and on the treatment of prompt injection in Appendix A. In summary: the discussion paper does not mention cybersecurity or section 524B, yet many GenAI-enabled devices will be cyber devices; existing 524B obligations (SBOM, postmarket monitoring plan, updates and patches) already provide part of the answer to Question 24 for third-party foundation models; prompt injection should be treated as a threat in the threat model as well as a benchmarking element; and Foundation Model MAFs could carry the security-relevant information sponsors cannot obtain on their own.

Comment of Vynix LLC (Omakyn) on Docket No. FDA-2026-N-7874
Submitted by Martin Gaspar Maciel, Founder, Vynix LLC (Omakyn). Omakyn prepares cybersecurity
documentation for medical device premarket submissions under section 524B of the FD&C Act. This
comment responds to Questions 24 and 25 and to the treatment of prompt injection in Appendix A.

1. The discussion paper does not address cybersecurity, and many GenAI-enabled devices will be
cyber devices

In the 30 pages of the discussion paper that carry text, the words "cybersecurity" and "security" do not
appear, and neither do "524B" or "software bill of materials". We counted on 27 September 2026 and again
on 12 October 2026. The paper does name, among the risks of these devices, "limited visibility into
underlying third-party foundation models".

We understand the paper "does not represent draft or final guidance", and that cybersecurity may be
addressed elsewhere. We raise it because the two frameworks will meet in the same submissions. Section
524B(c) defines a cyber device as one that "(1) includes software validated, installed, or authorized by the
sponsor as a device or in a device; (2) has the ability to connect to the internet; and (3) contains any such
technological characteristics validated, installed, or authorized by the sponsor that could be vulnerable to
cybersecurity threats." A device that calls a cloud-hosted foundation model appears to meet all three
conditions. The February 2026 premarket cybersecurity guidance already anticipates this: its security
objectives "generally may apply broadly to devices within the scope of this guidance, including, but not
limited to, devices containing artificial intelligence (AI) and cloud-based services."
We recommend that any future guidance on GenAI-enabled devices state how its considerations relate to
section 524B and the February 2026 guidance, so that sponsors do not build two separate records for the
same foundation model.

2. Question 24: existing section 524B obligations already provide part of the answer
Question 24 asks how a manufacturer can "detect, evaluate, and respond" to changes initiated by the
developer of a third-party foundation model. For a cyber device, the statute already requires three things
that bear directly on this:

Section 524B(b)(3) requires a software bill of materials "including commercial, open-source, and offthe-shelf software components". The February 2026 guidance states that "all software, including those
developed by the device manufacturer ('proprietary software') or obtained from third parties, should be
assessed for cybersecurity risk." A third-party foundation model is a software component obtained from
a third party.

Section 524B(b)(1) requires "a plan to monitor, identify, and address, as appropriate, in a reasonable
time, postmarket cybersecurity vulnerabilities and exploits".
Section 524B(b)(2) requires processes to "make available postmarket updates and patches to the device
and related systems".

We suggest that FDA consider the following, building on those obligations rather than adding a parallel
mechanism:

a) Identify the foundation model in the SBOM by provider, model identifier and version, and access
mode (a hosted API versus weights deployed by the sponsor). The guidance's existing recommendation to
include "the software level of support provided through monitoring and maintenance from the software
component manufacturer (e.g., the software is actively maintained, no longer maintained, abandoned)" and
"the software component's end-of-support date" maps directly onto model versioning and deprecation
schedules.

b) Include provider-side model changes and deprecation notices in the section 524B(b)(1)
monitoring plan. An unannounced change to a hosted model is detectable only if the sponsor monitors for
it, for example by pinning versions where the provider allows it and by re-running a fixed subset of the
premarket benchmarking elements on a defined schedule.

c) Define in advance what an upstream change triggers. The same event can be a performance question
(the competency-based assessment the paper discusses) and a cybersecurity question (a changed attack
surface). A sponsor who writes down, before clearance, which upstream changes require re-verification
answers both.

d) Use contracts for what monitoring cannot see. Advance notice of model version changes, deprecation
timelines and security incident notification from the model developer are the contractual mechanisms that
Question 24 anticipates.

3. Prompt injection is also a cybersecurity threat, not only a benchmarking element

In Appendix A, prompt injection appears as a benchmarking element: "Relevant testing may include
adversarial prompting, prompt injection, emotional-manipulation scenarios, and multi-turn
conversations", and, for agentic systems, "resistance to prompt injection through user inputs, retrieved
content, and tool outputs."

Injection through retrieved content and tool outputs is an attack path from outside the device, which places
it in the threat model as well as in the performance evaluation. The February 2026 guidance describes
threat modeling as "a process for identifying security objectives, risks, and vulnerabilities across the
medical device system". We recommend that FDA state that prompt injection testing can support both the
benchmarking elements and the cybersecurity risk assessment, so sponsors document it once and reference
it in both places.

4. Question 25: security-relevant content for Foundation Model MAFs
If voluntary Foundation Model MAFs are pursued, we suggest their content include the security-relevant
information a device sponsor cannot obtain on its own: the developer's versioning and deprecation policy,
its commitments on advance notice of changes, its vulnerability disclosure process, and known security
limitations of the model. This is the information a sponsor needs to fill the SBOM and monitoring plan
elements described above.
Sources read on 26 and 27 September 2026 and re-checked on 12 October 2026: the discussion paper
(FDA-2026-N-7874-0001); section 524B of the FD&C Act, 21 U.S.C. 360n-2 (Cornell LII); FDA,
Cybersecurity in Medical Devices: Quality Management System Considerations and Content of
Premarket Submissions (3 February 2026).
Martin Gaspar Maciel
Founder, Vynix LLC (Omakyn)
omakyn.com