Agent skill · research science · borghei
fda-consultant-specialist
FDA regulatory consultant for medical device companies, covering 510(k)/PMA/De Novo pathways, QSR (21 CFR 820), HIPAA, and device cybersecurity. Use for FDA submissions, predicate and substantial-equivalence analysis, and premarket strategy.
Why this skill is useful
Provides specific FDA submission pathways and compliance strategies that the AI wouldn't reliably generate on its own.
What it needs
About 11k tokens when loaded. Last updated 2026-07-21. 462 stars on the source repository.
What this skill does
FDA Consultant Specialist FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (QSR), HIPAA compliance, and device cybersecurity requirements. Table of Contents FDA Pathway Selection 510(k) Submission Process QSR Compliance HIPAA for Medical Devices Device Cybersecurity Resources --- Clarify First Before selecting a pathway or assessing compliance, confirm these inputs. If any is unknown or vague, ASK — do not assume: [ ] Device class and predicate — Class I/II/III and whether a predicate device exists (drives 510(k) vs De Novo vs PMA) [ ] Intended use / indications — what the device claims and its use environment (sets the substantial-equivalence argument and clinical-evidence needs) [ ] Software/AI nature — SaMD, adaptive AI needing a PCCP, or connected device (cybersecurity/SBOM) (changes the required documentation set) Stop rule: ask only the 2-3 that most change the output. If the user says "just draft it," proceed and list your assumptions at the top of the analysis. 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 Cost --------- ------------- ---------- ------ 510(k) Traditional Predicate exists, design changes 90 days $21,760 510(k) Special Manufacturing changes only 30 days $21,760 510(k) Abbreviated Guidance/standard conformance 30 days $21,760 De Novo Novel, low-moderate risk 150 days $134,676 PMA Class III, no predicate 180+ days $425,000+ 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 borghei/fda-consultant-specialist