Software as a Medical Device (SaMD) Compliance Dashboard
Product
Dr. Buddy AI — Psychiatric Decision Support System
Classification
Class II (De Novo or 510(k))
Risk Level
Moderate Risk — SaMD Category II (Treat or Diagnose, Non-Serious)
Regulatory Pathway
De Novo Classification Request (21 CFR 860.260)
Intended Use
AI-powered psychiatric screening and decision support tool that provides preliminary mental health assessments, risk scoring, and treatment recommendations to support clinical decision-making.
Overall Progress
Complete
In Progress
Not Started
ISO 13485:2016
IEC 62304:2006+A1:2015
ISO 14971:2019
FDA Clinical Evidence Guidance
FDA AI/ML SaMD Action Plan
FDA Cybersecurity Guidance 2023
21 CFR 801
HIPAA / 45 CFR Parts 160, 164
Establish QMS per ISO 13485
Implement Design Controls per 21 CFR 820.30
Begin Risk Management per ISO 14971
Complete IEC 62304 lifecycle documentation
Document AI/ML algorithms and training data
Conduct bias and fairness analysis
Design and execute analytical validation
Conduct prospective clinical study
Generate clinical evidence report
Submit Pre-Sub package to FDA
Pre-Submission meeting with FDA reviewers
Incorporate FDA feedback into submission strategy
Compile complete De Novo submission
Submit to FDA CDRH
Respond to any Additional Information requests
This portal is an internal tracking tool for FDA pre-submission preparation. It does not constitute legal or regulatory advice. All regulatory submissions must be reviewed by qualified regulatory affairs professionals and legal counsel before filing with the FDA. Russell Labs recommends engaging a regulatory consultant experienced in SaMD and AI/ML medical devices.