FDA Consultant Specialist
This skill provides FDA regulatory consulting for medical device manufacturers, covering submission pathways (510(k), PMA, De Novo), QMSR compliance (21 CFR 820 incorporating ISO 13485:2016), HIPAA assessments, and device cybersecurity. It produces pathway selection guidance, submission checklists, compliance frameworks, and risk assessment tools.
✨ What it does
- Provides a decision framework for selecting the appropriate FDA pathway based on predicate existence and device risk.
- Includes a detailed 510(k) submission workflow with required sections and common RTA issues.
- Maps legacy QSR sections to ISO 13485:2016 clauses under QMSR, with design controls and CAPA processes.
- Offers HIPAA applicability criteria and safeguard requirements (administrative, physical, technical).
- Covers premarket and postmarket cybersecurity requirements, including SBOM and vulnerability disclosure.
- Provides scripts for tracking submissions, checking QMS compliance, and running HIPAA risk assessments.
🎯 When to use it
- When the user asks about FDA submission pathways such as 510(k), PMA, or De Novo.
- When the user needs guidance on QMSR or ISO 13485 compliance for medical devices.
- When the user is assessing HIPAA requirements for a medical device that handles PHI.
- When the user needs to understand FDA cybersecurity requirements for connected devices.
🚀 How to use
Trigger the skill by mentioning FDA submission, 510(k), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity. The skill expects a description of the device and the specific regulatory question. Example prompts:
I need to determine the FDA pathway for a novel low-risk device with no predicate.
Help me prepare a 510(k) submission for my new blood glucose monitor.
📄 Output: The skill provides guidance documents, checklists, and decision frameworks, along with scripts for tracking submissions and assessing compliance.
📦 Add this skill to Claude Code
# 1. Get the skills repo
git clone --depth 1 https://github.com/alirezarezvani/claude-skills /tmp/claude-skills
# 2. Copy this skill into your project (or ~/.claude/skills for all projects)
mkdir -p .claude/skills
cp -r /tmp/claude-skills/ra-qm-team/skills/fda-consultant-specialist .claude/skills/fda-consultant-specialistSkill source: ra-qm-team/skills/fda-consultant-specialist/SKILL.md
⚠️ Good to know
The skill is informational and does not replace official FDA counsel; user fees and regulations change, so verify current requirements at fda.gov.
❓ FAQ
What is the difference between QSR and QMSR?
QMSR is the updated regulation effective 2026-02-02 that incorporates ISO 13485:2016 by reference, replacing the legacy QSR subsection structure.
When is a De Novo pathway appropriate?
De Novo is for novel devices with no predicate that are low-to-moderate risk, not high risk (Class III).
Does HIPAA apply to all medical devices?
No, HIPAA applies only if the device creates, stores, transmits, or accesses Protected Health Information (PHI), such as connected devices or those with EHR integration.
🤖 Overview, features, install steps and FAQ were generated from the project's SKILL.md on Sep 4, 2026. Always check the original source before running commands.