Agent skill · research science · alirezarezvani
fda-consultant-specialist
Use for FDA medical device questions: 510(k) vs De Novo vs PMA, predicates and substantial equivalence, QMSR (21 CFR 820), HIPAA or device cybersecurity. Runs fda_submission_tracker.py, qsr_compliance_checker.py and hipaa_risk_assessment.py.
Why this skill is useful
Provides a comprehensive decision framework and detailed workflows for FDA submission processes that are not commonly found in public resources.
What it needs
About 6k tokens when loaded. Last updated 2026-08-05. 23,939 stars on the source repository.
What this skill does
FDA Consultant Specialist FDA regulatory consulting for medical device manufacturers covering submission pathways, the Quality Management System Regulation (QMSR, 21 CFR Part 820 — formerly the QSR), HIPAA compliance, and device cybersecurity requirements. Table of Contents FDA Pathway Selection 510(k) Submission Process QMSR Compliance (formerly QSR) HIPAA for Medical Devices Device Cybersecurity Resources --- FDA Pathway Selection Determine the appropriate FDA regulatory pathway based on device classification and predicate availability. Decision Framework Pathway Comparison Pathway When to Use Timeline User Fee (FY2024) --------- ------------- ---------- ------------------- 510(k) Traditional Predicate exists, design changes 90 days $21,760 (FY2024) 510(k) Special Manufacturing changes only 30 days $21,760 (FY2024) 510(k) Abbreviated Guidance/standard conformance 30 days $21,760 (FY2024) De Novo Novel, low-moderate risk 150 days $134,676 (FY2024) PMA Class III, no predicate 180+ days $425,000+ (FY2024) User fees are set annually under MDUFA. Verify current-fiscal-year fees at fda.gov (MDUFA user fee schedule) before budgeting; small-business rates differ. Pre-Submission Strategy 1. Identify product code and classification 2. Search 510(k) database for predicates 3. Assess substantial equivalence feasibility 4. Prepare Q-Sub questions for FDA 5. Schedule Pre-Sub meeting if needed Reference: See fdasubmissionguide.md for pathway decision matrices and submission requirements. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills alirezarezvani/fda-consultant-specialist--da6e0b