FDA Device Classification
BetaMedical Devices
Beta. This skill is live and its measured eval results are published, but it has not been certified by Proofwork yet. Marketed devices whose registered product code was in the 25 candidates the find tool returns: 446/515 (n=515 devices described in their own GUDID records, first published 2026-03-01 to 2026-07-25 — after the 2025-09-30 corpus cutoff, and later than every case the retrieval parameters were tuned on. 86.6 per cent, 95 per cent Wilson interval 83.4 to 89.3. This measures whether the right code is in the list your assistant is shown, not whether it then picks it, and not whether FDA would agree with the labeler.).
FDA medical-device classification: candidate product codes, device class, the 21 CFR regulation behind them, the premarket pathway and cleared 510(k) predicate candidates.
This skill runs as an MCP server in your LLM workspace. It returns candidate FDA product codes grouped by 21 CFR regulation, each with device class, submission type, exemption and implant flags and FDA's own definition; the full record for a chosen code with its premarket pathway; and the 510(k)s already cleared under it. Proofwork never calls a model. It is a research aid, not regulatory advice, and it does not decide whether a product is a medical device — the statutory definition is returned for you to apply.
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Connect the skill to your LLM workspace and classify your first device.
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What each tool returns, where the FDA data comes from, its as-of dates and cutoff, and what the skill will not decide for you.
What's included
- Find candidate FDA product codes for a device description: class, submission type, exemption and implant flags, FDA's definition, examples
- Get the full record for one product code: 21 CFR identification text, premarket pathway, sibling codes, and what the record does not determine
- List cleared 510(k)s under a product code as predicate candidates, with K-numbers and FDA database links — a research list, not an SE opinion