openFDA Regulatory Metadata
PYPI · OPENFDA-MCP · SCANNED AUG 16
Resolve FDA application numbers and product names to regulatory metadata (CDER, CBER, CDRH).
Available components
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. How we score →
Supply Chain Security100
- No malware found by supply-chain analysis.Pass
- No known CVEs affecting this package version or its production dependencies.Pass
- Runs hatchling.build at install time, a recognised native-build step with no shell scripting around it. View diagnostics → Pass
- 1 of 19 dependencies flagged as unhealthy. View diagnostics → Partial
Provenance & Transparency32
- Source repository is publicly reachable at the declared URL. View diagnostics → Pass
- Provenance check failed: no build-provenance attestation is published. See how to fix → View diagnostics → Fail
- License check failed: the license (MIT License) isn't a recognized OSI-approved license. See how to fix → Fail
- Actively maintained (last published 9 days ago).Pass
- Disclosure check failed: no security disclosure policy was found in the source repository. See how to fix → Fail
Schema Quality & AI Usability84
- AI-judged instruction clarity (excellent).Pass
- Tool/resource definitions use about 705 tokens (~100/item across 7 items; 7 tools + 0 resources), lean.Pass
- Usage-examples check failed: none of the tools include examples. See how to fix → Fail
Stability & Change Management30
- Stability observed for 9 of 30 days with no destabilising changes; credit accrues until the full window elapses.Partial
Tool Coverage100
- 100% of tools have a non-trivial description (not blank, and not just the tool's name).Pass
- 100% of tool parameters carry a description.Pass
- Structured output schemas are declared (100% of tools); any adoption earns full credit.Pass
Capabilities100
- Implements a supported MCP spec version (2025-11-25); the latest is 2026-07-28.Pass
Add this component to your MCP client. Where a client-specific snippet is available, pick your client below and copy it straight into your config; otherwise use the connection detail shown.
pypi · openfda-mcp
claude mcp add com-blackswancausallabs-openfda-mcp -- uvx openfda-mcp
codex mcp add com-blackswancausallabs-openfda-mcp -- uvx openfda-mcp
{
"$schema": "https://opencode.ai/config.json",
"mcp": {
"com-blackswancausallabs-openfda-mcp": {
"type": "local",
"command": [
"uvx",
"openfda-mcp"
],
"enabled": true
}
}
} openclaw mcp add com-blackswancausallabs-openfda-mcp --command uvx --arg openfda-mcp
mcp_servers:
com-blackswancausallabs-openfda-mcp:
command: "uvx"
args: ["openfda-mcp"] {
"mcpServers": {
"com-blackswancausallabs-openfda-mcp": {
"command": "uvx",
"args": [
"openfda-mcp"
]
}
}
} Every change we have recorded for this component, newest first. Security-relevant changes are always shown. ▲ marks a change for the better, ▼ a change for the worse; unmarked changes are neutral.
- 16 Aug 26 +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.
- 14 Aug 26 +4
- Stability: unverified → 0.23 ▲ functional
- 13 Aug 26 +15
- Malware scan: unverified → pass ▲ security
- Security disclosure: unverified → fail ▼ functional
- 12 Aug 26 −15
- Malware scan: pass → unverified ▼ security
- Security disclosure: fail → unverified ▼ functional
- 11 Aug 26 +2
- We updated how we score, so this day's move reflects our rubric, not a change to the server See what changed → functional
- 8 Aug 26 +24
- Malware scan: unverified → pass ▲ security
- Schema quality: unverified → good ▲ functional
- 7 Aug 26 42
First indexed and scored.
Diagnostic detail from the automated scan of this channel: what the scanner observed at each step, so you can see exactly where a check passed or failed. It is informational only and never changes the trust score.
Captured 16 Aug 2026 · Analysed pypi/openfda-mcp@0.1.0
Provenance No attestation
The registry publishes no build provenance for this version, so there is nothing to verify.
| Result | No attestation |
|---|---|
| Ecosystem | pypi |
Install scripts 1 script
| Hook | Tier | Command |
|---|---|---|
| build_backend | allowlisted | hatchling.build |
Dependencies 19 packages
| Packages resolved | 19 |
|---|---|
| Stale | 1 |
| Tree resolution | Complete |
The tools this component advertises to a client, with an estimated token cost for each. Expand a tool to see its parameters and schema. The per-tool counts are indicative and are not scored directly; the schema's total context footprint is one signal in Schema Quality & AI Usability.
classify_device_product_code ~53
Resolve a CDRH product code to its device class and medical specialty.
| Name | Type | Req | Description |
|---|---|---|---|
| product_code | string | yes | The 3-letter CDRH product code, e.g. "HQD", "SDQ". |
Structured output declared, but exposes no named fields.
No examples provided.
lookup_device_submission ~112
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.
| Name | Type | Req | Description |
|---|---|---|---|
| number | string | yes | Device number with prefix. Case-insensitive. |
Structured output declared, but exposes no named fields.
No examples provided.
lookup_drugsfda_application ~75
Fetch Drugs@FDA application metadata for an NDA/BLA/ANDA number.
| Name | Type | Req | Description |
|---|---|---|---|
| application_number | string | yes | 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. |
Structured output declared, but exposes no named fields.
No examples provided.
resolve_drug_to_application ~122
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.
| Name | Type | Req | Description |
|---|---|---|---|
| drug_name | string | yes | Brand or generic name, e.g. "Adbry" or "tralokinumab". |
| limit | integer | – | Max label records to aggregate (default 10). |
Structured output declared, but exposes no named fields.
No examples provided.
screen_for_rwe_signals ~168
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.
| Name | Type | Req | Description |
|---|---|---|---|
| extra_terms | – | – | Additional quoted terms to add to the default screen. |
| limit_per_term | integer | – | Max label records per term (default 200). |
| Name | Type | Req | Description |
|---|---|---|---|
| result | array | yes | – |
No examples provided.
search_drug_label ~104
Search openFDA drug labels (SPL) for a term.
| Name | Type | Req | Description |
|---|---|---|---|
| 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 | yes | Search term. Quote multi-word phrases, e.g. '"natural history"'. |
Structured output declared, but exposes no named fields.
No examples provided.
validate_device_application ~71
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.
| Name | Type | Req | Description |
|---|---|---|---|
| number | string | yes | Device number with prefix (K/DEN/P/H). Case-insensitive. |
Structured output declared, but exposes no named fields.
No examples provided.