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FDA AI-enabled device list

ai_devices
Read-only

FDA's official Artificial Intelligence-Enabled Medical Devices list (1,500+ authorizations), tracked weekly by Atlas. List recent AI device authorizations, filter by panel or year, or check whether a specific submission number is on the list. openFDA itself has no AI field - this is the joined, queryable version.

Input Schema

TableJSON Schema
NameRequiredDescriptionDefault
yearNoFilter by decision year, e.g. 2025
limitNoMax results (default 15, max 40)
panelNoFilter by lead panel, e.g. Radiology, Cardiovascular
submission_numberNoCheck one submission, e.g. K254207 or DEN200001

TDQS

A4.2/5.0
Behavior4/5

Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?

Annotations already declare readOnlyHint=true and destructiveHint=false. The description adds useful behavioral context beyond that: the data source is FDA's official list, it contains 1,500+ authorizations, it is tracked weekly by Atlas, and it is a joined queryable dataset rather than the raw openFDA feed.

Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.

Conciseness5/5

Is the description appropriately sized, front-loaded, and free of redundancy?

Three sentences with no filler. The description front-loads the authoritative source and scope, lists concrete operations, and closes with the dataset's value proposition. Every sentence contributes distinct information.

Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.

Completeness4/5

Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?

For a read-only query tool with four optional parameters and no output schema, the description covers the source, the update cadence, and all main query modes. The only minor omission is the shape of the returned records, but the absence of an output schema and the clear list-oriented purpose keep this gap small.

Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.

Parameters3/5

Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?

Schema description coverage is 100%, so the schema already documents all four parameters. The description's mention of filtering by panel/year and checking a submission number mirrors the schema rather than adding new semantic detail, which lands at the baseline 3.

Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.

Purpose5/5

Does the description clearly state what the tool does and how it differs from similar tools?

The description states a specific verb/resource combo: list FDA AI-enabled medical device authorizations, with explicit operations like filtering by panel/year or checking a submission number. It also distinguishes itself from openFDA by noting this is the joined, queryable version.

Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.

Usage Guidelines4/5

Does the description explain when to use this tool, when not to, or what alternatives exist?

The tool's intended use cases are clearly enumerated: list recent authorizations, filter by panel or year, or check a submission number. It notes openFDA lacks an AI field, implying this tool is the right choice for AI-specific queries, though it does not explicitly name sibling tools or exclusion conditions.

Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.

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TDQS

A3.8/5.0
Disambiguation4/5

Each tool has a clear primary purpose: AI device list, predicate candidates, monitoring feed, clearance detail, product code stats, recall search, and general full-text search. Minor overlap exists between find_predicates and product_code_stats (both product-code driven) and between search_recalls and search_records, but the descriptions distinguish specialized from general use.

Naming Consistency4/5

Most tools follow a verb_noun pattern like find_predicates, get_changes, get_clearance, search_recalls, and search_records. Two names — ai_devices and product_code_stats — are noun phrases, creating a minor inconsistency, but the overall pattern remains readable and predictable.

Tool Count5/5

Seven tools is well-scoped for a read-only FDA data server, covering lookup, search, statistics, monitoring, and specialized research use cases without unnecessary duplication. Each tool earns its place.

Completeness4/5

The set covers clearance details, recall search, product code statistics, change monitoring, predicate research, and the AI device list. There is no dedicated clinical trial tool, though search_records includes trials, and no device classification lookup, but these are workable gaps rather than dead ends.

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