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Defense · FDA SaMD 510(k)/De Novo

FDA SaMD 510(k)/De Novo for defense AI workflows

FDA SaMD 510(k)/De Novo in defense AI workflows: what compliance requires, who asks for evidence, and the records to keep.

Legal forceBinding law (FD&C Act and 21 CFR); the AI lifecycle guidance is a non-binding draft
Applies fromPathways long in force; AI lifecycle guidance is a January 2025 draft
SectorDefense
Checked21 Oct 2026

01 / The rule

What FDA SaMD 510(k)/De Novo requires

Manufacturers marketing software, including AI software, that meets the FD&C Act definition of a medical device in the United States.

  1. 01Decide whether the software function is a device or falls under an exclusion such as non-device clinical decision support.
  2. 02Obtain 510(k) clearance, De Novo grant or PMA approval before marketing, matched to device risk class.
  3. 03Document model description, data management, validation and performance, including by subgroup, as the draft guidance recommends.
  4. 04Meet cybersecurity requirements for cyber devices under FD&C Act section 524B.
  5. 05Run a quality system under 21 CFR 820 and report adverse events under 21 CFR 803.
  6. 06File a new submission for significant changes unless covered by an authorized PCCP.

02 / In this sector

In a defense AI workflow

Most AI medical devices reach market through 510(k), with FDA listing over 1,600 authorized AI-enabled devices as of September 2026. The draft lifecycle guidance adds AI-specific expectations on data, bias, transparency and performance monitoring.

Usually asked by

Program office leads and ATO-package owners.

Named alongside

NIST AI RMF · DoW RAI · OMB M-25-21.

Sector pagePlanisphere for defense

03 / Records

Records to keep

  1. 01510(k) clearance letter, De Novo order or PMA approval
  2. 02Software and AI model documentation submitted to FDA
  3. 03Clinical or analytical validation reports with subgroup results
  4. 04Quality system design history file and complaint records

Optional evidence · where Planisphere fits

Keep a record anyone can check

When your team meets a duty, Planisphere can seal the event it reports as a receipt.

01 · Your teamRecord the event

A disclosure shown, a review signed, a model change approved: the event your system reports.

02 · PlanisphereSeal it

The event becomes a sealed receipt, dated and attributed to whoever is signed in.

03 · AnyoneCheck it

Paste the receipt into Verify. No account or key.

A record supports your compliance evidence process. It is not a legal finding or a certification. Systems that call Planisphere's gate API can also hold or refuse an action before it runs.

SOURCES

Go back to the source

SECONDARY
FDA Regulation of AI-Enabled Devices (CRS In Focus IF13245, June 10, 2026)

Congressional Research Service (via EveryCRSReport)

RELATED

Related: FDA SaMD 510(k)/De Novo: the full guide · FDA SaMD 510(k)/De Novo for medicine · FDA SaMD 510(k)/De Novo for law · FDA SaMD 510(k)/De Novo for education