Law · FDA PCCP / SaMD
FDA PCCP / SaMD for legal AI workflows
FDA PCCP / SaMD in legal AI workflows: what compliance requires, who asks for evidence, and the records to keep.
01 / The rule
What FDA PCCP / SaMD requires
Makers of standalone software that meets the device definition (Software as a Medical Device) and contains AI-enabled functions, when filing a 510(k), De Novo or PMA.
- 01Confirm the software meets the device definition and is not excluded, for example as non-device clinical decision support.
- 02Include a PCCP in the marketing submission with Description of Modifications, Modification Protocol and Impact Assessment.
- 03Limit planned modifications to changes that keep the SaMD within its authorized intended use and indications.
- 04Pre-specify data management, retraining, performance evaluation methods and acceptance criteria for each update.
- 05Tell users through labeling that the device has a PCCP and describe implemented changes and their performance.
- 06Keep version control and quality system records; submit a new application for changes outside the plan.
02 / In this sector
In a legal AI workflow
Most authorized PCCPs involve machine-learning software, and SaMD is where model retraining is most frequent. The guiding principles ask that plans be focused and bounded, risk-based, evidence-based, transparent and lifecycle-oriented.
General counsel and litigation support.
FRE 702 · ABA Model Rules.
03 / Records
Records to keep
- 01Authorized PCCP and marketing authorization letter
- 02Retraining dataset records and performance test reports per release
- 03Software version log mapped to PCCP modification types
- 04User-facing release notes or labeling updates
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.
SOURCES
Go back to the source
U.S. Food and Drug Administration
U.S. Food and Drug Administration
U.S. Food and Drug Administration
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