openFDA Regulatory Metadata
PYPI · OPENFDA-MCP · SCANNED SEP 14
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 → Why this is hard to score →
Supply Chain Security50
- Malware scan not yet available for this package.Unverified
- 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 20 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 38 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 Management80
- Stability observed for 24 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
Tool Safety100
- No prompt-injection markers were found in the server instructions, tool names or descriptions we captured.Pass
- We read all 7 captured tool definition(s), and no name or description among them implies an irreversible operation.Pass
- An AI judge read all 7 captured unit(s) of tool text and found none that tries to manipulate the model reading it.Pass
Capabilities100
- Implements a current MCP spec version (2026-07-28).Pass
How do I install the openFDA Regulatory Metadata MCP server?
openFDA Regulatory Metadata runs locally as a PyPI package, launched with uvx openfda-mcp. Ready-made configuration for Claude, Cursor, VS Code, Codex and 5 more is on this page, copied from each client's own documentation.
pypi · openfda-mcp
claude mcp add com-blackswancausallabs-openfda-mcp -- uvx openfda-mcp
{
"mcpServers": {
"com-blackswancausallabs-openfda-mcp": {
"command": "uvx",
"args": [
"openfda-mcp"
]
}
}
} {
"servers": {
"com-blackswancausallabs-openfda-mcp": {
"command": "uvx",
"args": [
"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": {
"Transport": "stdio",
"Command": "uvx",
"Arguments": [
"openfda-mcp"
]
}
}
} assistant mcp add com-blackswancausallabs-openfda-mcp -t stdio -c uvx -a 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.
- 14 Sept 26 −3
- Stability: pass → 0.80 functional
- 13 Sept 26 −14
- Malware scan: pass → unverified ▼ security
- Stability: 0.97 → pass security
- 12 Sept 26 +15
- Malware scan: unverified → pass ▲ security
- 11 Sept 26 +1
No change was recorded against any check on this day. Stability & Change Management went from 90 to 93. That category is still filling its 30-day observation window: 27 days of observed history at the previous scan, 28 at this one. The score rises as the window fills, whether or not the server changes.
- 9 Sept 26 +1
No change was recorded against any check on this day. Stability & Change Management went from 83 to 87. That category is still filling its 30-day observation window: 25 days of observed history at the previous scan, 26 at this one. The score rises as the window fills, whether or not the server changes.
- 8 Sept 26 −15
- Malware scan: pass → unverified ▼ security
- 7 Sept 26 −3
- Stability: pass → 0.80 functional
- 6 Sept 26 +1
- Stability: 0.97 → pass security
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 14 Sept 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 |
Background: How many MCP packages publish verified provenance →
Install scripts 1 script
| Hook | Tier | Command |
|---|---|---|
| build_backend | allowlisted | hatchling.build |
Background: Why install scripts are a supply-chain risk →
Dependencies 20 packages
| Packages resolved | 20 |
|---|---|
| Stale | 1 |
| Tree resolution | Complete |
Background: SBOMs and build attestations, explained →
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. A tool's description is untrusted text the model reads on every call, which is what makes this list a security surface and not just an inventory: how tool poisoning works →
classify_device_product_code 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 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 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 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 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 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 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.
What is the openFDA Regulatory Metadata MCP server?
openFDA Regulatory Metadata is an MCP server listed in the public MCP registry as com.blackswancausallabs/openfda-mcp. Resolve FDA application numbers and product names to regulatory metadata (CDER, CBER, CDRH). This page covers its PyPI package (openfda-mcp).
Is the openFDA Regulatory Metadata MCP server safe to use?
openFDA Regulatory Metadata scores 66 out of 100 on VerifyMCP. We found no known CVEs affecting it as of 14 September 2026. That is a record of what we were able to check automatically, not an endorsement. The category breakdown on this page shows every signal behind the number, including the ones we could not confirm.
What tools does the openFDA Regulatory Metadata MCP server expose?
openFDA Regulatory Metadata exposes 7 tools: search_drug_label, lookup_drugsfda_application, resolve_drug_to_application, screen_for_rwe_signals, lookup_device_submission, and 2 more. Their descriptions and schemas cost roughly 705 tokens of context every time the server is loaded.
Is the openFDA Regulatory Metadata MCP server still maintained?
openFDA Regulatory Metadata is still listed as active in the MCP registry. We last reached this channel on 14 September 2026. Those dates come from our own scans of the registry and the channel itself, not from anything the publisher announced.