United States (federal) · statute
FDA SaMD 510(k)/De Novo: what it requires, and the records to keep
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 FDA's January 2025 draft guidance sets out what an AI device submission should contain across the total product lifecycle.
01 / What it requires
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.
- 01Decide whether the software function is a device or falls under an exclusion such as non-device clinical decision support.
- 02Obtain 510(k) clearance, De Novo grant or PMA approval before marketing, matched to device risk class.
- 03Document model description, data management, validation and performance, including by subgroup, as the draft guidance recommends.
- 04Meet cybersecurity requirements for cyber devices under FD&C Act section 524B.
- 05Run a quality system under 21 CFR 820 and report adverse events under 21 CFR 803.
- 06File a new submission for significant changes unless covered by an authorized PCCP.
02 / AI work
Where it touches AI work
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.
03 / Dates
The dates that matter
FDA discussion paper on modifications to AI/ML-based SaMD
Draft AI-enabled device software functions lifecycle guidance issued
FDA issues final clinical decision support software guidance
Quality Management System Regulation (ISO 13485-aligned) takes effect
FDA lists over 1,600 authorized AI-enabled devices
04 / Enforcement
Who enforces it
FDA. Marketing an uncleared or unapproved device makes it adulterated and misbranded; remedies include warning letters, import refusal, seizure, injunction, civil money penalties and criminal prosecution.
05 / Records
Records an organisation keeps
What an auditor or an inquiry usually asks to see. Your obligations depend on your role and your facts.
- 01510(k) clearance letter, De Novo order or PMA approval
- 02Software and AI model documentation submitted to FDA
- 03Clinical or analytical validation reports with subgroup results
- 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.
A disclosure shown, a review signed, a model change approved: the event your system reports.
The event becomes a sealed receipt, dated and attributed to whoever is signed in.
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.
QUESTIONS
The questions that come next
Does my AI feature need FDA 510(k) or De Novo clearance?+
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. Read the full answer
SOURCES
Go back to the source
U.S. Food and Drug Administration
Congressional Research Service (via EveryCRSReport)
CHANGE LOG
What changed, and when
Rebuilt from primary sources; facts checked on this date.
Related: FDA SaMD 510(k)/De Novo for medicine AI workflows · NIST AI RMF · OMB M-25-21/22 · DoW RAI S&IP · EO 14179 · FIPS 140-3 · SHA-256 / FIPS 180-4