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SKILL

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.

Target: Target not categorized. Automatically collected · unverified.

Use with Claude Code

A guide for this combination is not available yet, and compatibility has not been verified.

Requirements

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