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fda-consultant-specialist

Guide FDA regulatory pathways for 510(k), De Novo, and PMA submissions.

Updated Mar 7, 2026
Search Tags:#compliance#cybersecurity#fda#regulatory#510k#medical device#qsr
One-click install
npx skills add https://github.com/tapanshah/Claude-Skills --skill fda-consultant-specialist-tapanshah
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: fda-consultant-specialist
Source: https://github.com/tapanshah/Claude-Skills/tree/main/ra-qm-team/fda-consultant-specialist
Command: npx skills add https://github.com/tapanshah/Claude-Skills --skill fda-consultant-specialist-tapanshah

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) components.

What problem does it solve?

This Skill provides expert guidance on complex FDA regulatory pathways and compliance requirements for medical device companies, simplifying the submission and quality system processes.

Core Features & Use Cases

  • Pathway Guidance: Helps determine the correct FDA submission pathway (510(k), De Novo, PMA).
  • QSR Compliance: Offers detailed information and workflows for 21 CFR 820 compliance.
  • HIPAA & Cybersecurity: Addresses critical regulatory aspects for connected devices.
  • Use Case: A startup developing a new connected medical device needs to understand FDA submission requirements and cybersecurity obligations. This Skill provides a comprehensive overview and actionable steps.

Quick Start

Use the fda-consultant-specialist skill to outline the steps for a traditional 510(k) submission.

Frequently Asked Questions about fda-consultant-specialist

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I determine the correct FDA regulatory pathway for a new medical device?▼

To determine the correct FDA regulatory pathway, you evaluate device classification and risk level to select the appropriate 510(k), De Novo, or PMA submission route. This Skill guides regulatory affairs professionals through these complex submission requirements.

What are the steps to outline a traditional 510(k) submission?▼

Outlining a traditional 510(k) submission involves identifying a predicate device, compiling substantial equivalence data, and preparing quality system documentation. This Skill provides actionable workflows to structure your 510(k) submission steps accurately.

How do I ensure 21 CFR 820 Quality System Regulation (QSR) compliance?▼

Ensuring 21 CFR 820 QSR compliance requires establishing comprehensive quality management workflows covering device design, production, and post-market controls. This Skill offers detailed information and workflows to help medical device manufacturers meet QSR standards.

What cybersecurity and HIPAA requirements apply to connected medical devices?▼

Connected medical devices must address HIPAA requirements and device cybersecurity to protect patient data and mitigate network vulnerabilities. This Skill provides critical regulatory guidance and actionable steps for managing cybersecurity obligations in connected devices.

When do I need a De Novo classification request instead of a 510(k)?▼

A De Novo classification request is needed for low-to-moderate risk novel devices without a legally marketed predicate, whereas a 510(k) applies to devices with an existing equivalent. This Skill helps determine the correct pathway based on your device profile.

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