fda-consultant-specialist

Guide FDA medical device submission pathway selection and compliance documentation.

Updated Apr 16, 2026

Search Tags:#fda #regulatory #510k #hipaa #medical-device #pma #denovo

Ready to run

npx skills add https://github.com/devCharuzu/philfida-taskmanage --skill fda-consultant-specialist-devcharuzu

💬 Prompt for ChatGPT / Claude Chat▼

Please help me install this Agent Skill.
Skill: fda-consultant-specialist
Source: https://github.com/devCharuzu/philfida-taskmanage/tree/main/.windsurf/skills/fda-consultant-specialist
Command: npx skills add https://github.com/devCharuzu/philfida-taskmanage --skill fda-consultant-specialist-devcharuzu

SYSTEM DOCUMENTATION & REQUIREMENTS

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

What problem does it solve?

FDA regulatory navigation for medical device teams who need to choose submission pathways, ensure QSR/HIPAA compliance, and prepare documentation efficiently.

Core Features & Use Cases

Pathway guidance: helps determine whether a device fits 510(k), De Novo, or PMA.
Compliance templates: provides checklists, templates, and decision matrices for FDA submissions, QSR, HIPAA risk management, and cybersecurity.
Reference materials: directs to official FDA guidance and templates to streamline submissions.

Quick Start

State your device and intended use to begin assembling the recommended FDA submission plan.

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 submission pathway for a medical device?▼

To determine an FDA submission pathway, define your device and intended use, then use a structured decision framework to evaluate eligibility for 510(k), De Novo, or PMA. This evaluates device risk and predicate availability to recommend the correct route.

What is the difference between 510(k), De Novo, and PMA submissions?▼

510(k) requires proving substantial equivalence to a predicate, De Novo classifies novel low-to-moderate risk devices, and PMA requires rigorous clinical data for high-risk devices. Decision matrices compare these pathways based on risk level and predicate availability.

How do I prepare QSR and HIPAA compliance documentation for a medical device?▼

Prepare QSR and HIPAA compliance documentation by utilizing structured checklists and templates that align with FDA guidance. These tools help structure risk management and cybersecurity readiness assessments for medical device submissions.

Do I need a cybersecurity risk assessment for my FDA medical device submission?▼

Cybersecurity readiness is evaluated as part of FDA regulatory guidance for medical devices. Structured templates and checklists help assess cybersecurity risks and integrate the necessary controls into your submission documentation.

When should I choose a De Novo classification instead of a 510(k)?▼

Choose a De Novo pathway when your medical device is low-to-moderate risk but lacks a valid predicate for a 510(k). Decision frameworks evaluate your device specifics to determine if De Novo classification is the appropriate route.

Can I get FDA submission templates and checklists for medical device compliance?▼

FDA submission templates and checklists are provided for QSR compliance, HIPAA risk management, and pathway selection. These structured documents align with official FDA guidance to streamline assembling your medical device submission plan.