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fda-consultant-specialist

Assess FDA regulatory pathways and submission readiness for medical devices.

3|1|Updated Dec 21, 2025
Search Tags:#compliance#fda#submission#hipaa#medical-device#qsr#regulatory-strategy
One-click install
npx skills add https://github.com/I-Onlabs/claude-code-skills --skill fda-consultant-specialist-i-onlabs
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: fda-consultant-specialist
Source: https://github.com/I-Onlabs/claude-code-skills/tree/main/fda-consultant-specialist
Command: npx skills add https://github.com/I-Onlabs/claude-code-skills --skill fda-consultant-specialist-i-onlabs

SYSTEM DOCUMENTATION & REQUIREMENTS

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

What problem does it solve?

Identify and navigate FDA regulatory pathways for medical devices, delivering clear strategies to reduce time to market and risk.

Core Features & Use Cases

  • Regulatory Pathway Analysis: Classify device pathway (510(k), PMA, De Novo) and plan submissions with timelines.
  • QSR & HIPAA Guidance: Align design controls, quality management, and data protection with 21 CFR 820 and HIPAA requirements.
  • Submission Planning & Management: Compile, coordinate, and respond to FDA requests, including pre-submission planning and post-submission activities.
  • Cybersecurity & Post-Market Support: Implement FDA cybersecurity guidance and ongoing lifecycle compliance, including post-market surveillance.

Quick Start

Provide a regulatory strategy assessment and an actionable plan for FDA submission readiness for your device.

Frequently Asked Questions about fda-consultant-specialist

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

FAQPage Schema
What is the best way to determine an FDA regulatory pathway for a new medical device?▼

Assess FDA regulatory pathways by classifying your device for 510(k), De Novo, or PMA submissions. The pathway analysis applies structured decision frameworks and risk assessments to deliver an actionable submission timeline and strategy.

How do I plan for an FDA pre-submission and manage post-submission activities?▼

Plan FDA pre-submissions by compiling coordinated documentation and regulatory strategies. The framework manages submission readiness and generates plans to respond to FDA requests and handle ongoing post-submission activities.

Can I use this framework for both pre-market submission planning and post-market lifecycle management?▼

Yes, the framework assesses pre-market submission readiness for 510(k), De Novo, and PMA pathways while supporting post-market lifecycle management. It delivers actionable strategies for the entire medical device regulatory lifecycle.

Do I need specific risk assessment data to start FDA submission planning?▼

Yes, providing device risk assessment data is required to assess FDA submission readiness accurately. The framework uses structured decision frameworks and your risk data to generate actionable regulatory strategies and documentation plans.

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