Get Started

Beta

Add FDA Device Classification to your AI assistant in under a minute. One URL, any client.

Beta. This skill is live, but it has not been certified by Proofwork yet.

Add the server

Any MCP-compatible client can connect using the server URL:

https://mcp.proofworklabs.com/mcp

Claude: open Customize → Connectors, click Add custom connector, and paste the URL.
ChatGPT: turn on Developer mode under Settings → Security and login, then go to chatgpt.com/plugins, click the plus button, and paste the URL.
Other clients: add the URL as a remote MCP server.

Leave OAuth fields empty. Authentication is handled automatically. See the connector docs for client-specific details.

On first use, a browser window opens for sign-in. Use your Google, Microsoft, or email account. This happens once — your session is remembered.

Try this in your AI assistant:

"What FDA product code covers a single-use sterile urinary drainage catheter?"

"Is product code LZA 510(k) exempt, and what regulation is it under?"

"Show me recent 510(k) clearances under HWC so I can research predicates."

Your AI will call the skill tools automatically:

Find candidate product codes from the device description and intended use find_fda_device_codes_payload
Pull the full record for the chosen code and read its pathway get_fda_product_code_payload
Review the 510(k)s already cleared under that code find_fda_predicate_candidates_payload

Free tier: 500 MCP tool calls per organization, pooled across every Proofwork skill. No credit card required. See pricing for unlimited access.