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Check a drug or medical device approval, classification or shortage

regaffairs_check_drug_or_device_approval
Read-onlyIdempotent

Checks whether a medicine is authorised in a market, with its approval details and shortage status, or a medical device's classification, registration, approval or notified body. Medicines: the FDA Orange Book (approved drugs, therapeutic equivalence, patents and exclusivity), EMA authorised medicines, EMA orphan designations, the EMA, FDA and MHRA shortage lists, the Health Canada Drug Product Database (DIN) and Notice of Compliance database. Devices: the FDA device classification database (product codes, device class, regulation number), FDA De Novo decisions and PMA approvals, FDA MAUDE adverse event reports, MHRA guidance on registering devices for the GB market, EU NANDO notified bodies under the MDR and IVDR, the CDSCO approved device lists (India) and the Italian national medical devices database. Not intended for GMP or ICH guidance (regaffairs_find_pharma_gmp_and_ich_guidance covers that), for MDR or IVDR legal requirements, or for clinical trials.

Input Schema

NameRequiredDescriptionDefault
includeNo
productYesMedicine brand or active ingredient, DIN, NDA/ANDA number, device name, FDA product code (e.g. 'DXY'), PMA number or notified body number.
product_kindNoany
jurisdictionsNoDefault: all held for the product kind.

Output Schema

NameRequiredDescriptionDefault
resultsYes
sourcesYes
not_foundYes
truncatedYes

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 establish readOnly, idempotent, non-destructive and closed-world behavior, so the safety profile is covered. The description goes further by disclosing exactly which data sources back the answer per jurisdiction and per facet (Orange Book, EMA, shortage lists, MAUDE, NANDO, CDSCO, etc.), which is meaningful coverage/trust context beyond the structured fields.

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

Conciseness4/5

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

Front-loaded with the core purpose in the first clause, then organized as Medicines / Devices / Not-intended. It is dense and list-heavy, but each listed source maps to a data facet or enum value, so most of the length earns its place. Minor redundancy between the title and opening sentence.

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?

With an output schema present, return-value explanation is unnecessary, and annotations cover the safety profile. The description supplies source coverage, jurisdictional scope and facet mapping, leaving only edge behavior (no-match results, cross-kind ambiguity) unstated. Adequate-to-strong for a tool of this scope.

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 coverage is only 50%, so the description must compensate, and it does: the enumerated sources map directly onto the `include` enum values (shortage lists, orphan designations, MAUDE adverse events, NANDO notified bodies, FDA device classification), giving the agent a basis for choosing facets. `product` and `jurisdictions` already carry schema descriptions, and the medicine-vs-device framing clarifies `product_kind`, though it doesn't state input formats or behavior for ambiguous products.

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?

States a specific verb (checks/retrieves) plus the two distinct resources it spans — a medicine's authorisation/shortage status and a device's classification, registration, approval or notified body. The description lets an agent distinguish it from siblings like regaffairs_check_chemical_substance or regaffairs_check_pesticide_approval_and_mrl without opening any schema.

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?

Provides explicit exclusions and names the alternative: 'Not intended for GMP or ICH guidance (regaffairs_find_pharma_gmp_and_ich_guidance covers that), for MDR or IVDR legal requirements, or for clinical trials.' That is clear routing guidance. It lacks a positive 'use this when' phrasing relative to other checking siblings, so it stops short of a full 5.

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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