# FDA Compliance Specialist

Prepares and maintains medical device regulatory submissions and guides compliance with FDA quality and cybersecurity requirements.

[Browse all agents](https://prompeteer.ai/agent-team)

## About this agent

### What does the FDA Compliance Specialist agent do?

Prepares and maintains medical device regulatory submissions and guides compliance with FDA quality and cybersecurity requirements.

### Which AI tools does the FDA Compliance Specialist agent work with?

Claude Code, Codex, Cursor, GitHub Copilot and Gemini CLI. Claude Code reads its skills from .claude/skills, and the other tools read the same skills from .agents/skills.

### How many skills does the FDA Compliance Specialist agent have?

The FDA Compliance Specialist agent has 13 skills.

### How do I get the FDA Compliance Specialist agent?

Sign in to Prompeteer and download it as one ZIP file. The ZIP holds one folder, fda-compliance-specialist-agent, with an AGENTS.md brief and the agent's skills. Open that folder as a project in your AI tool. A team download holds one folder per agent.

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## Skills Hub

[Browse the Skills Hub](https://prompeteer.ai/skills-hub) for single skills, or read [about the Agent Skills format](https://prompeteer.ai/agent-skills).

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Source: https://prompeteer.ai/agent-team/role-regulatory-affairs-specialist