Fda Devices

Fda Device Pma Search

fda_device_pma_search

Read-onlyIdempotent

Search FDA Premarket Approval (PMA) decisions and supplements by trade/generic name, applicant, product code, PMA number, or CLINICAL INDICATION/condition text (via indication). Which diagnostic tests are FDA-approved: covers high-risk IN VITRO DIAGNOSTIC (IVD) tests approved via PMA, including companion diagnostics and molecular residual disease (MRD) / ctDNA monitoring tests (e.g. Signatera, Guardant360 CDx) -- these are FDA-approved tests, not cleared devices, so this tool (not 510(k)) is the one that finds them. indication matches free text in FDA's own published approval-order narrative (ao_statement) -- the intended-use/indication language FDA wrote when it approved the device -- so a caller who describes what a test DOES or what condition/biomarker it monitors (without knowing any brand name) can still find it; device only matches the trade/generic NAME field and returns nothing for a condition-only question. Supplements may represent manufacturing or labeling changes rather than new devices, so a supplement's own ao_statement can be a narrow procedural note (e.g. "approval of a post-approval study protocol") rather than the full clinical indication -- pass several synonymous indication phrases (FDA's exact wording varies by product and rarely matches a lay term) rather than one exact phrase.

Input Schema

TableJSON Schema

Name	Required	Description
`limit`	No	Results (1-100, default 20).
`device`	No	Trade or generic device name substring.
`to_date`	No	Latest decision date, YYYY-MM-DD.
`applicant`	No	Applicant/company substring.
`from_date`	No	Earliest decision date, YYYY-MM-DD.
`indication`	No	One or more clinical indication / intended-use / condition phrases, OR'd together, matched as exact phrases against the FDA approval-order narrative text (ao_statement) -- NOT the device name. Use this instead of (or with) `device` when the caller names a condition/biomarker/what-it-monitors rather than a brand, e.g. for "MRD or ctDNA monitoring in solid tumors" pass ["circulating tumor DNA","molecular residual disease","minimal residual disease","cell-free DNA","ctDNA","MRD"] -- FDA's actual wording varies by product (Guardant360 CDx's approval says "cell-free DNA (cfDNA)", never "ctDNA"), so pass several synonyms rather than one exact phrase; each phrase is matched literally (no stemming/tokenizing), so an overly narrow or misspelled phrase silently finds nothing.
`pma_number`	No	Exact PMA number, optionally including supplement suffix.
`product_code`	No	Exact FDA product code.

Output Schema

TableJSON Schema

Name	Required	Description	Default
`total`	Yes
`source`	Yes
`returned`	Yes
`approvals`	Yes

Schema Changelog

Changes observed during successful MCP inspections.

Changed2 schema fields changedSep 28, 2026

changedInput schema / examples

Previous value: -[
-  {
-    "applicant": "Medtronic",
-    "from_date": "2025-01-01",
-    "limit": 10
-  }
-]New value: +[
+  {
+    "applicant": "Medtronic",
+    "from_date": "2025-01-01",
+    "limit": 10
+  },
+  {
+    "indication": [
+      "circulating tumor DNA",
+      "molecular residual disease",
+      "minimal residual disease",
+      "cell-free DNA",
+      "ctDNA",
+      "MRD"
+    ]
+  }
+]

addedInput schema / properties / indication

Added value: +{
+  "description": "One or more clinical indication / intended-use / condition phrases, OR'd together, matched as exact phrases against the FDA approval-order narrative text (ao_statement) -- NOT the device name. Use this instead of (or with) `device` when the caller names a condition/biomarker/what-it-monitors rather than a brand, e.g. for \"MRD or ctDNA monitoring in solid tumors\" pass [\"circulating tumor DNA\",\"molecular residual disease\",\"minimal residual disease\",\"cell-free DNA\",\"ctDNA\",\"MRD\"] -- FDA's actual wording varies by product (Guardant360 CDx's approval says \"cell-free DNA (cfDNA)\", never \"ctDNA\"), so pass several synonyms rather than one exact phrase; each phrase is matched literally (no stemming/tokenizing), so an overly narrow or misspelled phrase silently finds nothing.",
+  "items": {
+    "type": "string"
+  },
+  "type": "array"
+}

First observedJul 27, 2026

TDQS

A4.5/5.0

Behavior4/5

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

Annotations already cover the safety profile (readOnly, idempotent, non-destructive, openWorld), but the description adds non-obvious behavior: `indication` matches FDA's ao_statement free text, phrases are matched literally with no stemming (silent no-results on misspelling), and a supplement's ao_statement may be a narrow procedural note rather than the clinical indication. This is meaningful disclosure beyond the annotations.

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

Conciseness3/5

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

Purpose is front-loaded, but the body is one very dense run-on with heavy parentheticals and em-dashes. It repeats itself — the synonym-passing advice and the ao_statement explanation each appear twice — which hurts scannability.

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 zero-required-param search tool with full schema coverage, annotations, and an output schema, the description supplies everything an agent needs: when to use it, how the free-text matching behaves, and its failure modes. Nothing material is missing.

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 100% and the schema's `indication` entry already documents ao_statement matching and synonym advice, so much of the description's param content overlaps the schema. However, the description adds the interaction semantics between `device` and `indication` (name field vs. narrative text) that help a caller choose correctly.

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+resource (search FDA Premarket Approval decisions and supplements) and enumerates the searchable fields. Crucially it distinguishes itself from the sibling fda_device_510k_search by explaining that PMA covers FDA-approved high-risk IVDs while 510(k) covers cleared devices.

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

Usage Guidelines5/5

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

Explicitly routes the caller: use `indication` when a condition/biomarker/what-it-monitors is named, `device` when a brand name is known, and it warns that `device` returns nothing for condition-only questions. It also advises passing multiple synonymous indication phrases rather than one exact phrase.

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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