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FDA Medical Device Classification

openfda_devices.reference.classification
Read-onlyIdempotent

Search FDA medical device classification database — 7,000+ product codes with risk class and regulatory requirements. Returns device name, product code, device class (1=low/exempt, 2=moderate/510k, 3=high/PMA), medical specialty, regulation number, definition, life-sustain/implant flags. Filter by device name, product code, device class, or specialty description. Device class determines the regulatory pathway: Class I (General Controls), Class II (510k), Class III (PMA). Source: FDA CDRH device classification database, US public domain.

Input Schema

TableJSON Schema
NameRequiredDescriptionDefault
skipNoNumber of records to skip for pagination (default 0).
limitNoNumber of records to return (1–99, default 10).
searchNoOpenFDA search expression using Lucene syntax. Single field: device_name:"pacemaker" or recall_status:"Ongoing". Combined: device_name:"insulin pump"+AND+recall_status:"Ongoing". Omit to return recent records sorted by date.

Output Schema

TableJSON Schema
NameRequiredDescriptionDefault
errorNoPresent only when the call failed. Includes error code, message, request_id, and any provider-specific extras.
resultNoTool response payload. Shape varies per tool — consult the tool description and inputSchema. May be an object, array, string, or number depending on the upstream provider response.

Schema Changelog

Changes observed during successful MCP inspections.

  1. First observed

TDQS

A4.3/5.0
Behavior4/5

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

Annotations already declare readOnlyHint, idempotentHint, and destructiveHint false. The description adds meaningful context beyond that: data source, scale (~7,000 product codes), result fields, device class semantics, and public-domain provenance. It does not discuss rate limits or pagination behavior, but the annotation coverage lowers the burden.

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?

Four sentences, front-loaded with the main action and scope, followed by return fields, filters, regulatory meaning, and source. Every sentence earns its place; there is no filler or repetition beyond the minor overlap between the class definitions and the pathway explanation.

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

Completeness5/5

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

For a read-only reference lookup with full schema coverage, a rich output schema, and strong annotations, this description is complete: it states the resource, what is returned, how to filter, what the class values mean, and the data source. An agent has enough information to select and invoke the tool correctly.

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

Parameters4/5

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

Schema description coverage is 100%, so the baseline is 3. The description adds value beyond the schema by naming the meaningful filter dimensions: device name, product code, device class, and specialty description, and by explaining what class values 1/2/3 mean for regulatory pathways. It does not provide exact field-name syntax for every filter, but the schema already supplies Lucene examples.

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 opens with a specific action and resource: 'Search FDA medical device classification database', then names concrete outputs such as product code, device class, medical specialty, and regulation number. This makes it clearly distinct from sibling tools like 510k clearance, adverse events, and recalls.

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

Usage Guidelines3/5

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

The description gives clear implied context for classification questions by listing supported filters and explaining regulatory pathways. However, it never explicitly tells the agent when to use this tool versus sibling openFDA device tools such as openfda_devices.clearance.premarket_510k, openfda_devices.safety.adverse_events, or openfda_devices.safety.recalls.

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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