# FDA - AI based SaMD

## FDA - AI based SaMD

- [FDA - AI based SaMD](https://documentations.seclea.com/fda-ai-based-samd/fda-ai-based-samd.md)
- [Data Governance (DG)](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg.md)
- [DG01 - Define Sets](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg01-define-sets.md)
- [DG02 - Dataset Governance Policies](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg02-dataset-governance-policies.md)
- [DG03 - Dataset Design Choices](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg03-dataset-design-choices.md)
- [DG04 - Dataset Source Information](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg04-dataset-source-information.md)
- [DG05 - Dataset Annotations Information](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg05-dataset-annotations-information.md)
- [DG06 - Dataset Labels Information](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg06-dataset-labels-information.md)
- [DG07 - Dataset Cleaning](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg07-dataset-cleaning.md)
- [DG08 - Dataset Enrichment](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg08-dataset-enrichment.md)
- [DG09 - Dataset Aggregation](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg09-dataset-aggregation.md)
- [DG10 - Dataset Description, Assumptions and Purpose](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg10-dataset-description-assumptions-and-purpose.md)
- [DG11 - Dataset Transformation Rationale](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg11-dataset-transformation-rationale.md)
- [DG12 - Dataset Bias Identification](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg12-dataset-bias-identification.md)
- [DG13 - Dataset Bias Mitigation](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg13-dataset-bias-mitigation.md)
- [DG14 - Dataset Bias Analysis Action and Assessment](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg14-dataset-bias-analysis-action-and-assessment.md)
- [DG15 - Dataset Gaps and Shortcomings](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg15-dataset-gaps-and-shortcomings.md)
- [DG16 - Dataset Bias Monitoring - Ongoing](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg16-dataset-bias-monitoring-ongoing.md)
- [DG17 - Dataset Bias Special/Protected Categories](https://documentations.seclea.com/fda-ai-based-samd/data-governance-dg/dg17-dataset-bias-special-protected-categories.md)
- [Technical Documentation (TD)](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td.md)
- [TD01 - Technical Documentation Generated](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td01-technical-documentation-generated.md)
- [TD02 - Additional Technical Documentation](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td02-additional-technical-documentation.md)
- [TD03 - Technical Details](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td03-technical-details.md)
- [TD04 - Development steps and methods](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td04-development-steps-and-methods.md)
- [TD05 - Pre-trained or Third party tools/systems](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td05-pre-trained-or-third-party-tools-systems.md)
- [TD06 - Design specification](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td06-design-specification.md)
- [TD07 - System Architecture](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td07-system-architecture.md)
- [TD08 - Computational Resources](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td08-computational-resources.md)
- [TD09 - Data Requirements](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td09-data-requirements.md)
- [TD10 - Human Oversight Assessment](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td10-human-oversight-assessment.md)
- [TD11 - Pre Determined Changes](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td11-pre-determined-changes.md)
- [TD12 - Continuous Compliance](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td12-continuous-compliance.md)
- [TD13 - Validation and Testing](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td13-validation-and-testing.md)
- [TD14 - Monitoring, Function and Control](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td14-monitoring-function-and-control.md)
- [TD15 - Risk Management System](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td15-risk-management-system.md)
- [TD16 - Changes](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td16-changes.md)
- [TD17 - Other Technical Standards](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td17-other-technical-standards.md)
- [TD18 - Ongoing Monitoring System](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td18-ongoing-monitoring-system.md)
- [TD19 - Reports Signed](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td19-reports-signed.md)
- [Transparency and Provision of Information to Users (TPI)](https://documentations.seclea.com/fda-ai-based-samd/transparency-and-provision-of-information-to-users-tpi.md)
- [TPI01 - Transparency of the AI System](https://documentations.seclea.com/fda-ai-based-samd/transparency-and-provision-of-information-to-users-tpi/tpi01-transparency-of-the-ai-system.md)
- [TPI02 - Instructions for Use](https://documentations.seclea.com/fda-ai-based-samd/transparency-and-provision-of-information-to-users-tpi/tpi02-instructions-for-use.md)
- [Human Oversight (HO)](https://documentations.seclea.com/fda-ai-based-samd/human-oversight-ho.md)
- [HO01 - Human Oversight Mechanism](https://documentations.seclea.com/fda-ai-based-samd/human-oversight-ho/ho01-human-oversight-mechanism.md)
- [HO02 - Human Oversight Details](https://documentations.seclea.com/fda-ai-based-samd/human-oversight-ho/ho02-human-oversight-details.md)
- [HO03 - Human Oversight - Biometric Identification Systems](https://documentations.seclea.com/fda-ai-based-samd/human-oversight-ho/ho03-human-oversight-biometric-identification-systems.md)
- [Accuracy, Robustness and Cybersecurity (ARC)](https://documentations.seclea.com/fda-ai-based-samd/accuracy-robustness-and-cybersecurity-arc.md)
- [ARC01 - Accuracy Levels](https://documentations.seclea.com/fda-ai-based-samd/accuracy-robustness-and-cybersecurity-arc/arc01-accuracy-levels.md)
- [ARC02 - Robustness Assessment](https://documentations.seclea.com/fda-ai-based-samd/accuracy-robustness-and-cybersecurity-arc/arc02-robustness-assessment.md)
- [ARC03 - Continuous Learning Feedback Loop Assessment](https://documentations.seclea.com/fda-ai-based-samd/accuracy-robustness-and-cybersecurity-arc/arc03-continuous-learning-feedback-loop-assessment.md)
- [ARC04 - Cyber Security Assessment](https://documentations.seclea.com/fda-ai-based-samd/accuracy-robustness-and-cybersecurity-arc/arc04-cyber-security-assessment.md)
- [Managing SaMD Lifecycle Support Process - Record Keeping (RK)](https://documentations.seclea.com/fda-ai-based-samd/managing-samd-lifecycle-support-process-record-keeping-rk.md)
- [RK01 - Logging Capabilities](https://documentations.seclea.com/fda-ai-based-samd/managing-samd-lifecycle-support-process-record-keeping-rk/rk01-logging-capabilities.md)
- [RK02 - Logging Traceability](https://documentations.seclea.com/fda-ai-based-samd/managing-samd-lifecycle-support-process-record-keeping-rk/rk02-logging-traceability.md)
- [RK03 - Logging - Situations that May Cause AI Risk](https://documentations.seclea.com/fda-ai-based-samd/managing-samd-lifecycle-support-process-record-keeping-rk/rk03-logging-situations-that-may-cause-ai-risk.md)
- [RK04 - Logging - Biometric systems requirements](https://documentations.seclea.com/fda-ai-based-samd/managing-samd-lifecycle-support-process-record-keeping-rk/rk04-logging-biometric-systems-requirements.md)
- [RK05 - Details of Off-the-Shelf Components](https://documentations.seclea.com/fda-ai-based-samd/managing-samd-lifecycle-support-process-record-keeping-rk/rk05-details-of-off-the-shelf-components.md)
- [RK06 - Evaluation Process of Off-the-Shelf Components](https://documentations.seclea.com/fda-ai-based-samd/managing-samd-lifecycle-support-process-record-keeping-rk/rk06-evaluation-process-of-off-the-shelf-components.md)
- [RK07 - Quality Control Process of Off-the-Shelf Components](https://documentations.seclea.com/fda-ai-based-samd/managing-samd-lifecycle-support-process-record-keeping-rk/rk07-quality-control-process-of-off-the-shelf-components.md)
- [RK08 - Internal Audit Reports](https://documentations.seclea.com/fda-ai-based-samd/managing-samd-lifecycle-support-process-record-keeping-rk/rk08-internal-audit-reports.md)
- [Risk Management System (RMS)](https://documentations.seclea.com/fda-ai-based-samd/risk-management-system-rms.md)
- [RMS01 - Risk Management System in Place](https://documentations.seclea.com/fda-ai-based-samd/risk-management-system-rms/rms01-risk-management-system-in-place.md)
- [RMS02 - Risk Management System Capabilities and Processes](https://documentations.seclea.com/fda-ai-based-samd/risk-management-system-rms/rms02-risk-management-system-capabilities-and-processes.md)
- [RMS03 - Risk Management Measures](https://documentations.seclea.com/fda-ai-based-samd/risk-management-system-rms/rms03-risk-management-measures.md)
- [RMS04 - Testing](https://documentations.seclea.com/fda-ai-based-samd/risk-management-system-rms/rms04-testing.md)
- [RMS05 - Residual Risks](https://documentations.seclea.com/fda-ai-based-samd/risk-management-system-rms/rms05-residual-risks.md)
- [RMS06 - Full Track of Mitigation Measures](https://documentations.seclea.com/fda-ai-based-samd/risk-management-system-rms/rms06-full-track-of-mitigation-measures.md)
- [Quality Management Principles (QMP)](https://documentations.seclea.com/fda-ai-based-samd/quality-management-principles-qmp.md)
- [QMP01 - Quality Management System in Place](https://documentations.seclea.com/fda-ai-based-samd/quality-management-principles-qmp/qmp01-quality-management-system-in-place.md)
- [QMP02 - Compliance Strategy stated](https://documentations.seclea.com/fda-ai-based-samd/quality-management-principles-qmp/qmp02-compliance-strategy-stated.md)
- [QMP03 - Design processes](https://documentations.seclea.com/fda-ai-based-samd/quality-management-principles-qmp/qmp03-design-processes.md)
- [QMP04 - Development and QA (Quality Assurance) processes](https://documentations.seclea.com/fda-ai-based-samd/quality-management-principles-qmp/qmp04-development-and-qa-quality-assurance-processes.md)
- [QMP05 - Test and Validation Procedures](https://documentations.seclea.com/fda-ai-based-samd/quality-management-principles-qmp/qmp05-test-and-validation-procedures.md)
- [QMP06 - Technical Standards](https://documentations.seclea.com/fda-ai-based-samd/quality-management-principles-qmp/qmp06-technical-standards.md)
- [QMP07 - Data Management Procedures](https://documentations.seclea.com/fda-ai-based-samd/quality-management-principles-qmp/qmp07-data-management-procedures.md)
- [QMP08 - Risk Management System](https://documentations.seclea.com/fda-ai-based-samd/quality-management-principles-qmp/qmp08-risk-management-system.md)
- [QMP09 - Ongoing Monitoring System](https://documentations.seclea.com/fda-ai-based-samd/quality-management-principles-qmp/qmp09-ongoing-monitoring-system.md)
- [QMP10 - Incident Reporting Procedures](https://documentations.seclea.com/fda-ai-based-samd/quality-management-principles-qmp/qmp10-incident-reporting-procedures.md)
- [QMP11 - Communications with Competent Authorities](https://documentations.seclea.com/fda-ai-based-samd/quality-management-principles-qmp/qmp11-communications-with-competent-authorities.md)
- [QMP12 - Record Keeping Procedures](https://documentations.seclea.com/fda-ai-based-samd/quality-management-principles-qmp/qmp12-record-keeping-procedures.md)
- [QMP13 - Resource Management Procedures](https://documentations.seclea.com/fda-ai-based-samd/quality-management-principles-qmp/qmp13-resource-management-procedures.md)
- [QMP14 - Accountability Framework](https://documentations.seclea.com/fda-ai-based-samd/quality-management-principles-qmp/qmp14-accountability-framework.md)
- [Post Market Monitoring System (PMS)](https://documentations.seclea.com/fda-ai-based-samd/post-market-monitoring-system-pms.md)
- [PMS01 - Post Market Monitoring System in Place](https://documentations.seclea.com/fda-ai-based-samd/post-market-monitoring-system-pms/pms01-post-market-monitoring-system-in-place.md)
- [PMS02 - Data Collection Assessment](https://documentations.seclea.com/fda-ai-based-samd/post-market-monitoring-system-pms/pms02-data-collection-assessment.md)
- [PMS03 - Post Market Monitoring Plan](https://documentations.seclea.com/fda-ai-based-samd/post-market-monitoring-system-pms/pms03-post-market-monitoring-plan.md)