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Question · FDA SaMD 510(k)/De Novo

Does my AI feature need FDA 510(k) or De Novo clearance?

AI software that diagnoses, treats or predicts disease is usually a medical device and needs FDA marketing authorization: 510(k) clearance if substantially equivalent to a predicate, De Novo for novel low-to-moderate-risk devices, or PMA for high-risk Class III devices.

AboutFDA SaMD 510(k)/De Novo
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
Checked21 Oct 2026

01 / The answer

The short answer

It does if the feature is a medical device function, meaning software intended to diagnose, cure, mitigate, treat or prevent disease, and it is not excluded, for example as non-device clinical decision support or a general wellness product. Device software needs 510(k) clearance if a legally marketed predicate exists, a De Novo grant if it is novel and low-to-moderate risk, or premarket approval if it is high risk (Class III). Most of the more than 1,600 AI-enabled devices FDA had authorized by September 2026 came through 510(k). FDA revised its clinical decision support guidance in January 2026.
FDA SaMD 510(k)/De Novo · checked 21 Oct 2026

02 / The rule

What FDA SaMD 510(k)/De Novo requires

AI software that diagnoses, treats or predicts disease is usually a medical device and needs FDA marketing authorization: 510(k) clearance if substantially equivalent to a predicate, De Novo for novel low-to-moderate-risk devices, or PMA for high-risk Class III devices. FDA's January 2025 draft guidance sets out what an AI device submission should contain across the total product lifecycle.

  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  3. 03Document model description, data management, validation and performance, including by subgroup, as the draft guidance recommends.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.

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