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therealchandlerbing
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FDA Consultant Agent

Classify medical devices and outline FDA premarket submission pathways.

Updated Aug 23, 2026
Search Tags:#510k#QSR#FDA compliance#medical device#regulatory strategy#health tech#PMA
One-click install
npx skills add https://github.com/therealchandlerbing/claude-usecases --skill fda-consultant-agent
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: FDA Consultant Agent
Source: https://github.com/therealchandlerbing/claude-usecases/tree/main/.claude/skills/fda-consultant-agent
Command: npx skills add https://github.com/therealchandlerbing/claude-usecases --skill fda-consultant-agent

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes references (resource) components.

What problem does it solve?

Navigating complex FDA regulations for medical devices and health tech is challenging, time-consuming, and critical for market entry, often requiring expensive external consultants. This Skill provides accessible, expert-level guidance to streamline regulatory pathways.

Core Features & Use Cases

  • Device Classification: Assists in determining the correct FDA classification for medical devices, a crucial first step in the regulatory process.
  • Premarket Submission Guidance: Provides step-by-step advice for 510(k), PMA, and De Novo submissions, clarifying complex requirements.
  • Quality System Regulations (QSR): Offers insights into compliance with 21 CFR Part 820 requirements, ensuring robust quality management.
  • Use Case: Provide details of a new diagnostic software and receive guidance on its FDA classification, required premarket submission pathway, and a checklist for 510(k) preparation.

Quick Start

Classify our new AI-powered diagnostic software for cardiac arrhythmia detection and outline the required FDA premarket submission pathway.