United States (federal) · guidance
FDA PCCP / SaMD: what it requires, and the records to keep
For SaMD, a standalone software product with a medical purpose, a PCCP lets the maker pre-authorize planned model updates such as retraining on new data or tuning performance, so frequent software releases do not each need a new FDA submission. It matters because SaMD models change faster than hardware devices, and without a PCCP many model changes would require a new 510(k) or PMA supplement.
01 / What it requires
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 / AI work
Where it touches AI work
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.
03 / Dates
The dates that matter
FDA SaMD page adopts IMDRF definition of Software as a Medical Device
FDA, Health Canada and MHRA publish PCCP guiding principles
Draft PCCP guidance for all medical devices issued
Final PCCP guidance for AI-enabled device software functions issued
FDA issues final clinical decision support software guidance
04 / Enforcement
Who enforces it
FDA. Releasing a modified SaMD outside the authorized PCCP without a required submission can render it adulterated or misbranded, leading to warning letters, recalls or other enforcement.
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.
- 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
CHANGE LOG
What changed, and when
Rebuilt from primary sources; facts checked on this date.
Related: FDA PCCP / SaMD vs HIPAA · FDA PCCP / SaMD 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