# openFDA Regulatory Metadata (pypi · openfda-mcp)

Resolve FDA application numbers and product names to regulatory metadata (CDER, CBER, CDRH).

- Trust score: 73/100 (medium)
- Change this week: +7
- Registry status: active
- Liveness: live
- Owner verified: no
- Last scored: 2026-08-16

## Components

- pypi · `openfda-mcp`: 73/100 (this document), [markdown](https://verifymcp.io/servers/com-blackswancausallabs-openfda-mcp/openfda-mcp.md), [page](https://verifymcp.io/servers/com-blackswancausallabs-openfda-mcp/openfda-mcp)

## Channel facts

- Registry: `pypi`
- Package: `openfda-mcp`
- Version: `0.1.0`
- Transport: `stdio`

## Trust breakdown

How this component scores in each security and reliability category. Every signal is checked automatically from public evidence about the published package, including repeated runs of it in an isolated sandbox, and we only credit what we can confirm. Scores are 0–100 per category. Scoring method: https://verifymcp.io/docs/scoring (what has changed: https://verifymcp.io/docs/scoring/changelog)

Scored 2026-08-16.

- **Supply Chain Security**: 100/100
  - No malware found by supply-chain analysis.
  - No known CVEs affecting this package version or its production dependencies.
  - Runs hatchling.build at install time, a recognised native-build step with no shell scripting around it.
  - 1 of 19 dependencies flagged as unhealthy.
- **Provenance & Transparency**: 32/100
  - Source repository is publicly reachable at the declared URL.
  - Provenance check failed: no build-provenance attestation is published.
  - License check failed: the license (MIT License) isn't a recognized OSI-approved license.
  - Actively maintained (last published 9 days ago).
  - Disclosure check failed: no security disclosure policy was found in the source repository.
- **Schema Quality & AI Usability**: 84/100
  - AI-judged instruction clarity (excellent).
  - Tool/resource definitions use about 705 tokens (~100/item across 7 items; 7 tools + 0 resources), lean.
  - Usage-examples check failed: none of the tools include examples.
- **Stability & Change Management**: 30/100
  - Stability observed for 9 of 30 days with no destabilising changes; credit accrues until the full window elapses.
- **Tool Coverage**: 100/100
  - 100% of tools have a non-trivial description (not blank, and not just the tool's name).
  - 100% of tool parameters carry a description.
  - Structured output schemas are declared (100% of tools); any adoption earns full credit.
- **Capabilities**: 100/100
  - Implements a supported MCP spec version (2025-11-25); the latest is 2026-07-28.

## Install

### Claude

```bash
claude mcp add com-blackswancausallabs-openfda-mcp -- uvx openfda-mcp
```

### Codex

```bash
codex mcp add com-blackswancausallabs-openfda-mcp -- uvx openfda-mcp
```

### opencode

```json
{
  "$schema": "https://opencode.ai/config.json",
  "mcp": {
    "com-blackswancausallabs-openfda-mcp": {
      "type": "local",
      "command": [
        "uvx",
        "openfda-mcp"
      ],
      "enabled": true
    }
  }
}
```

### OpenClaw

```bash
openclaw mcp add com-blackswancausallabs-openfda-mcp --command uvx --arg openfda-mcp
```

### Hermes

```yaml
mcp_servers:
  com-blackswancausallabs-openfda-mcp:
    command: "uvx"
    args: ["openfda-mcp"]
```

### Other

```json
{
  "mcpServers": {
    "com-blackswancausallabs-openfda-mcp": {
      "command": "uvx",
      "args": [
        "openfda-mcp"
      ]
    }
  }
}
```

## Changelog

Every change recorded for this component, newest first. Days that predate change tracking, or that we cannot explain, say so: "we were watching and nothing happened" and "we were not watching" are different claims.

### 2026-08-16 (score 73, +1)

No change was recorded against any check on this day. Stability & Change Management went from 27 to 30. That category is still filling its 30-day observation window: 8 days of observed history at the previous scan, 9 at this one. The score rises as the window fills, whether or not the server changes.

### 2026-08-14 (score 72, +4)

- [functional improvement] Stability: unverified → 0.23

### 2026-08-13 (score 68, +15)

- [security improvement] Malware scan: unverified → pass
- [functional regression] Security disclosure: unverified → fail

### 2026-08-12 (score 53, −15)

- [security regression] Malware scan: pass → unverified
- [functional regression] Security disclosure: fail → unverified

### 2026-08-11 (score 68, +2)

- [functional] We updated how we score, so this day's move reflects our rubric, not a change to the server

### 2026-08-08 (score 66, +24)

- [security improvement] Malware scan: unverified → pass
- [functional improvement] Schema quality: unverified → good

### 2026-08-07 (score 42)

First indexed and scored.

## MCP tools (7)

### `search_drug_label` (~104 tokens)

Search openFDA drug labels (SPL) for a term.

Input parameters:

- `limit` (integer): Max results per page (1-1000, default 100).
- `section`: Optional SPL section to scope to (e.g. "clinical_studies"). Defaults to searching the RWE-relevant sections together.
- `skip` (integer): Pagination offset.
- `term` (string, required): Search term. Quote multi-word phrases, e.g. '"natural history"'.

### `lookup_drugsfda_application` (~75 tokens)

Fetch Drugs@FDA application metadata for an NDA/BLA/ANDA number.

Input parameters:

- `application_number` (string, required): The number WITH its prefix ("NDA021436", "BLA761180"). Case-insensitive. A bare digit string will not match — Drugs@FDA stores the prefix as part of the value.

### `resolve_drug_to_application` (~122 tokens)

Resolve a brand or generic drug name to its NDA/BLA application number(s).

Bridges drug-name-only sources (registry inventories, product lists) to FDA
regulatory metadata. Searches the brand and generic name fields directly
rather than label prose, so another product merely *mentioning* this drug
does not produce a false match.

Input parameters:

- `drug_name` (string, required): Brand or generic name, e.g. "Adbry" or "tralokinumab".
- `limit` (integer): Max label records to aggregate (default 10).

### `screen_for_rwe_signals` (~168 tokens)

EXPERIMENTAL. Sweep drug labels for registry / real-world-evidence signals.

Searches the label corpus for terms suggesting registry, natural-history or
other real-world evidence, then aggregates hits by application number with
snippets showing where each term matched.

\**This tool is unvalidated and has a known false-positive problem.** It has
no ground-truth oracle, and below the strongest hits the results are
dominated by applications whose labels use "registry" in an unrelated sense.
Its output is a candidate list for human review — not a finding, and not a
count you should report.

Input parameters:

- `extra_terms`: Additional quoted terms to add to the default screen.
- `limit_per_term` (integer): Max label records per term (default 200).

Output parameters:

- `result` (array)

### `lookup_device_submission` (~112 tokens)

Look up a CDRH device submission by its number.

Handles all four device pathways: 510(k) K-numbers ("K203571"), De Novo
grants ("DEN160026" — stored in the 510(k) endpoint, not a separate one),
PMA P-numbers ("P230044"), and HDE H-numbers. Supplement suffixes
("P230044/S001") are stripped before lookup.

Input parameters:

- `number` (string, required): Device number with prefix. Case-insensitive.

### `classify_device_product_code` (~53 tokens)

Resolve a CDRH product code to its device class and medical specialty.

Input parameters:

- `product_code` (string, required): The 3-letter CDRH product code, e.g. "HQD", "SDQ".

### `validate_device_application` (~71 tokens)

Validate a device number and derive class, specialty and category in one call.

Chains lookup_device_submission -> classify_device_product_code, which is
the full three-hop resolution: number -> product_code -> classification.

Input parameters:

- `number` (string, required): Device number with prefix (K/DEN/P/H). Case-insensitive.

## Diagnostics

Captured diagnostic sections: Provenance, Install scripts, Dependencies. The full working is on the page: https://verifymcp.io/servers/com-blackswancausallabs-openfda-mcp/openfda-mcp#diagnostics

## Score history

- 2026-08-16: 73
- 2026-08-15: 72
- 2026-08-14: 72
- 2026-08-13: 68
- 2026-08-12: 53
- 2026-08-11: 68
- 2026-08-10: 66
- 2026-08-09: 66
- 2026-08-08: 66
- 2026-08-07: 42

## Links

- PyPI project: https://pypi.org/project/openfda-mcp/
- Socket report: https://socket.dev/pypi/package/openfda-mcp
- Repository: https://github.com/Black-Swan-Causal-Labs/openfda-mcp
- Changelog RSS feed: https://verifymcp.io/servers/com-blackswancausallabs-openfda-mcp/openfda-mcp.xml
- Changelog JSON feed: https://verifymcp.io/servers/com-blackswancausallabs-openfda-mcp/openfda-mcp.json
- HTML version of this page: https://verifymcp.io/servers/com-blackswancausallabs-openfda-mcp/openfda-mcp