fda-mcp 0.1.0__tar.gz

fda_mcp-0.1.0/.claude/settings.json

@@ -0,0 +1,5 @@
+{
+	"env": {
+		"CLAUDE_CODE_EXPERIMENTAL_AGENT_TEAMS": "1"
+	}
+}

fda_mcp-0.1.0/.claude/settings.local.json

@@ -0,0 +1,6 @@
+{
+  "sandbox": {
+    "enabled": true,
+    "autoAllowBashIfSandboxed": true
+  }
+}

fda_mcp-0.1.0/.gitignore

@@ -0,0 +1,10 @@
+__pycache__/
+*.py[cod]
+*.egg-info/
+dist/
+build/
+.venv/
+.env
+*.pdf
+.pytest_cache/
+.ruff_cache/

fda_mcp-0.1.0/CLAUDE.md

@@ -0,0 +1,62 @@
+# CLAUDE.md
+
+This file provides guidance to Claude Code (claude.ai/code) when working with code in this repository.
+
+## Project Overview
+
+FDA MCP — an MCP server providing access to FDA data via the OpenFDA API. Wraps all 21 OpenFDA endpoints plus FDA decision document retrieval into 12 MCP tools optimized for LLM consumption.
+
+## Development Commands
+
+- **Install dependencies**: `uv sync --all-extras`
+- **Run server**: `uv run fda-mcp`
+- **Run unit tests**: `uv run pytest`
+- **Run integration tests** (hits real FDA API): `uv run pytest -m integration`
+- **Run specific test file**: `uv run pytest tests/test_endpoints.py -v`
+
+## Architecture
+
+- **Language**: Python 3.11+, async throughout
+- **MCP SDK**: `mcp` with FastMCP decorator API
+- **HTTP Client**: `httpx` (async)
+- **PDF Extraction**: `pdfplumber` + `pytesseract`/`pdf2image` OCR fallback
+- **Transport**: stdio (standard for Claude Desktop / Claude Code)
+
+### Source Layout
+
+```
+src/fda_mcp/
+├── server.py          -- FastMCP server entry point
+├── config.py          -- Environment-based configuration
+├── errors.py          -- Custom error types
+├── openfda/           -- OpenFDA API client layer
+│   ├── endpoints.py   -- Enum of all 21 endpoints
+│   ├── client.py      -- Async HTTP client with rate limiting
+│   └── summarizer.py  -- Response summarization per endpoint
+├── documents/         -- FDA decision document retrieval
+│   ├── urls.py        -- URL pattern construction
+│   └── fetcher.py     -- PDF download + text extraction
+├── tools/             -- 12 MCP tool handlers
+│   ├── search.py      -- 9 search tools
+│   ├── count.py       -- count_records tool
+│   ├── fields.py      -- list_searchable_fields tool
+│   └── decision_documents.py
+└── resources/         -- 3 MCP resources
+    ├── query_syntax.py
+    ├── endpoints_resource.py
+    └── field_definitions.py
+```
+
+## Configuration
+
+- `OPENFDA_API_KEY` — optional API key for higher rate limits (240 req/min vs 40)
+- `OPENFDA_TIMEOUT` — request timeout in seconds (default: 30)
+- `OPENFDA_MAX_CONCURRENT` — max concurrent API requests (default: 4)
+- `FDA_PDF_TIMEOUT` — PDF download timeout in seconds (default: 60)
+- `FDA_PDF_MAX_LENGTH` — default max text chars from PDFs (default: 8000)
+
+## Code Standards
+
+- Python 3.11+ with type hints throughout
+- Async functions for all I/O operations
+- Tests use pytest + pytest-asyncio + respx for HTTP mocking

fda_mcp-0.1.0/LICENSE

@@ -0,0 +1,21 @@
+MIT License
+
+Copyright (c) 2026 Limecooler
+
+Permission is hereby granted, free of charge, to any person obtaining a copy
+of this software and associated documentation files (the "Software"), to deal
+in the Software without restriction, including without limitation the rights
+to use, copy, modify, merge, publish, distribute, sublicense, and/or sell
+copies of the Software, and to permit persons to whom the Software is
+furnished to do so, subject to the following conditions:
+
+The above copyright notice and this permission notice shall be included in all
+copies or substantial portions of the Software.
+
+THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR
+IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY,
+FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE
+AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER
+LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM,
+OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE
+SOFTWARE.

fda_mcp-0.1.0/PKG-INFO

@@ -0,0 +1,291 @@
+Metadata-Version: 2.4
+Name: fda-mcp
+Version: 0.1.0
+Summary: MCP server providing access to FDA data via the OpenFDA API
+License-Expression: MIT
+License-File: LICENSE
+Keywords: fda,healthcare,llm,mcp,openfda
+Classifier: Development Status :: 4 - Beta
+Classifier: Intended Audience :: Developers
+Classifier: License :: OSI Approved :: MIT License
+Classifier: Programming Language :: Python :: 3
+Classifier: Programming Language :: Python :: 3.11
+Classifier: Programming Language :: Python :: 3.12
+Classifier: Programming Language :: Python :: 3.13
+Classifier: Topic :: Scientific/Engineering :: Medical Science Apps.
+Requires-Python: >=3.11
+Requires-Dist: httpx>=0.27.0
+Requires-Dist: mcp[cli]>=1.26.0
+Requires-Dist: pdf2image>=1.17.0
+Requires-Dist: pdfplumber>=0.11.0
+Requires-Dist: pydantic>=2.0.0
+Requires-Dist: pytesseract>=0.3.10
+Provides-Extra: dev
+Requires-Dist: pytest-asyncio>=0.23; extra == 'dev'
+Requires-Dist: pytest>=8.0; extra == 'dev'
+Requires-Dist: respx>=0.22.0; extra == 'dev'
+Description-Content-Type: text/markdown
+
+# FDA MCP Server
+
+An MCP (Model Context Protocol) server that provides LLM-optimized access to FDA data through the [OpenFDA API](https://open.fda.gov/) and direct FDA document retrieval. Covers all 21 OpenFDA endpoints plus regulatory decision documents (510(k) summaries, De Novo decisions, PMA approval letters).
+
+## Features
+
+- **12 MCP tools** covering drug, device, food, and other FDA data
+- **3 MCP resources** for query syntax help, endpoint reference, and field discovery
+- **All 21 OpenFDA endpoints** organized into 9 search tools by outcome, not endpoint
+- **FDA decision documents** — downloads and extracts text from 510(k) summaries, De Novo decisions, PMA approvals, SSEDs, and supplements
+- **OCR fallback** for scanned PDF documents (older FDA submissions)
+- **Context-efficient responses** — summarized output, field discovery on demand, pagination guidance
+- **Optional API key** support for higher rate limits
+
+## Tools
+
+### Search Tools (9)
+
+| Tool | Endpoints | Discriminator |
+|------|-----------|---------------|
+| `search_adverse_events` | drug/event, device/event, food/event | `product_type` |
+| `search_recalls` | drug/enforcement, device/enforcement, food/enforcement, device/recall | `product_type`, `source` |
+| `search_drug_labels` | drug/label | — |
+| `search_drugs` | drug/drugsfda, drug/ndc | `source` |
+| `search_drug_shortages` | drug/shortage | — |
+| `search_device_submissions` | device/510k, device/pma, device/classification, device/registrationlisting | `submission_type` |
+| `search_device_udi` | device/udi | — |
+| `search_substances` | other/substance, other/unii, other/nsde | `source` |
+| `search_other` | other/historicaldocument, device/covid19serology | `dataset` |
+
+All search tools accept `search` (OpenFDA query string), `limit`, `skip`, and `sort` parameters.
+
+### Cross-Cutting Tools (3)
+
+| Tool | Purpose |
+|------|---------|
+| `count_records` | Aggregation queries on any endpoint. Returns counts with percentages and narrative summary. |
+| `list_searchable_fields` | Returns searchable field names for any endpoint. Keeps field docs out of tool descriptions. |
+| `get_decision_document` | Fetches FDA regulatory decision PDFs and extracts text. Supports 510(k), De Novo, PMA, SSED, and supplement documents. |
+
+### Resources (3)
+
+| URI | Content |
+|-----|---------|
+| `fda://reference/query-syntax` | OpenFDA query syntax: AND/OR/NOT, wildcards, date ranges, exact matching |
+| `fda://reference/endpoints` | All 21 endpoints with descriptions |
+| `fda://reference/fields/{endpoint}` | Per-endpoint field reference |
+
+## Installation
+
+Requires Python 3.11+ and [uv](https://docs.astral.sh/uv/).
+
+```bash
+git clone <repo-url> fda-mcp
+cd fda-mcp
+uv sync
+```
+
+### Optional: OCR support for scanned PDFs
+
+Many older FDA documents (pre-2010) are scanned images. To extract text from these:
+
+```bash
+# macOS
+brew install tesseract poppler
+
+# Linux (Debian/Ubuntu)
+apt install tesseract-ocr poppler-utils
+```
+
+Without these, the server will still work — it returns a helpful message when it encounters a scanned document it can't read.
+
+## Usage with Claude Desktop
+
+Add to your `claude_desktop_config.json`:
+
+```json
+{
+  "mcpServers": {
+    "fda": {
+      "command": "uv",
+      "args": ["--directory", "/absolute/path/to/fda-mcp", "run", "fda-mcp"],
+      "env": {
+        "OPENFDA_API_KEY": "your-key-here"
+      }
+    }
+  }
+}
+```
+
+The `OPENFDA_API_KEY` is optional. Without it, you get 40 requests/minute. With a key (free from [open.fda.gov](https://open.fda.gov/apis/authentication/)), you get 240 requests/minute.
+
+### Config file location
+
+- **macOS**: `~/Library/Application Support/Claude/claude_desktop_config.json`
+- **Windows**: `%APPDATA%\Claude\claude_desktop_config.json`
+
+## Usage with Claude Code
+
+Add the server to your project's `.claude/settings.json` or global settings:
+
+```json
+{
+  "mcpServers": {
+    "fda": {
+      "command": "uv",
+      "args": ["--directory", "/absolute/path/to/fda-mcp", "run", "fda-mcp"],
+      "env": {
+        "OPENFDA_API_KEY": "your-key-here"
+      }
+    }
+  }
+}
+```
+
+Or add it interactively with `/mcp` in Claude Code.
+
+## Example Queries
+
+Once connected, you can ask Claude things like:
+
+- "Search for adverse events related to OZEMPIC"
+- "Find all Class I device recalls from 2024"
+- "What are the most common adverse reactions reported for LIPITOR?"
+- "Get the 510(k) summary for K213456"
+- "Search for PMA approvals for cardiovascular devices"
+- "How many drug recalls has Pfizer had? Break down by classification."
+- "Find the drug label for metformin and summarize the warnings"
+- "What COVID-19 serology tests has Abbott submitted?"
+
+## Configuration
+
+All configuration is via environment variables:
+
+| Variable | Default | Description |
+|----------|---------|-------------|
+| `OPENFDA_API_KEY` | *(none)* | API key for higher rate limits (240 vs 40 req/min) |
+| `OPENFDA_TIMEOUT` | `30` | HTTP request timeout in seconds |
+| `OPENFDA_MAX_CONCURRENT` | `4` | Max concurrent API requests |
+| `FDA_PDF_TIMEOUT` | `60` | PDF download timeout in seconds |
+| `FDA_PDF_MAX_LENGTH` | `8000` | Default max text characters extracted from PDFs |
+
+## OpenFDA Query Syntax
+
+The `search` parameter on all tools uses OpenFDA query syntax:
+
+```
+# AND
+patient.drug.openfda.brand_name:"ASPIRIN"+AND+serious:1
+
+# OR (space = OR)
+brand_name:"ASPIRIN" brand_name:"IBUPROFEN"
+
+# NOT
+NOT+classification:"Class III"
+
+# Date ranges
+decision_date:[20230101+TO+20231231]
+
+# Wildcards (trailing only, min 2 chars)
+device_name:pulse*
+
+# Exact matching (required for count queries)
+patient.reaction.reactionmeddrapt.exact:"Nausea"
+```
+
+Use `list_searchable_fields` or the `fda://reference/query-syntax` resource for the full reference.
+
+## Development
+
+```bash
+# Install with dev dependencies
+uv sync --all-extras
+
+# Run unit tests (157 tests, no network)
+uv run pytest
+
+# Run integration tests (hits real FDA API)
+OPENFDA_TIMEOUT=60 uv run pytest -m integration
+
+# Run a specific test file
+uv run pytest tests/test_endpoints.py -v
+
+# Start the server directly
+uv run fda-mcp
+```
+
+### Project Structure
+
+```
+src/fda_mcp/
+├── server.py              # FastMCP server entry point
+├── config.py              # Environment-based configuration
+├── errors.py              # Custom error types
+├── openfda/
+│   ├── endpoints.py       # Enum of all 21 endpoints
+│   ├── client.py          # Async HTTP client with rate limiting
+│   └── summarizer.py      # Response summarization per endpoint
+├── documents/
+│   ├── urls.py            # FDA document URL construction
+│   └── fetcher.py         # PDF download + text extraction + OCR
+├── tools/
+│   ├── search.py          # 9 search tool handlers
+│   ├── count.py           # count_records tool
+│   ├── fields.py          # list_searchable_fields tool
+│   └── decision_documents.py
+└── resources/
+    ├── query_syntax.py    # Query syntax reference
+    ├── endpoints_resource.py
+    └── field_definitions.py
+```
+
+### Test Structure
+
+```
+tests/
+├── test_endpoints.py                    # Endpoint enum
+├── test_openfda_client.py               # HTTP client
+├── test_summarizer.py                   # Response summarizers (21 endpoints)
+├── test_document_urls.py                # URL construction
+├── test_document_fetcher.py             # PDF extraction + OCR
+├── test_tool_search_*.py                # 9 search tool test files
+├── test_tool_count_records.py           # Count tool
+├── test_tool_list_fields.py             # Fields tool
+├── test_tool_decision_documents.py      # Document tool
+├── test_resources.py                    # MCP resources
+├── test_error_handling.py               # Error cases
+└── integration/
+    ├── test_live_openfda.py             # Live API (21 endpoints)
+    └── test_live_documents.py           # Live PDF fetch
+```
+
+## How It Works
+
+### Context Efficiency
+
+The server is designed to minimize context window usage when used by LLMs:
+
+1. **Response summarization** — Each endpoint type has a custom summarizer that extracts key fields and flattens nested structures. Drug labels truncate sections to 2,000 chars. PDF text defaults to 8,000 chars.
+
+2. **Field discovery via tool** — Instead of listing all searchable fields in tool descriptions (which would cost ~8,000-11,000 tokens of persistent context), the `list_searchable_fields` tool provides them on demand.
+
+3. **Smart pagination** — Default page sizes are low (10 records). Responses include `total_results`, `showing`, and `has_more`. When results exceed 100, a tip suggests using `count_records` for aggregation.
+
+4. **Count enrichment** — `count_records` returns values with pre-calculated percentages and a one-sentence narrative summary.
+
+### FDA Decision Documents
+
+These documents are **not** available through the OpenFDA API. The server constructs URLs and fetches directly from `accessdata.fda.gov`:
+
+| Document Type | URL Pattern |
+|--------------|-------------|
+| 510(k) summary | `https://www.accessdata.fda.gov/cdrh_docs/reviews/{K_NUMBER}.pdf` |
+| De Novo decision | `https://www.accessdata.fda.gov/cdrh_docs/reviews/{DEN_NUMBER}.pdf` |
+| PMA approval | `https://www.accessdata.fda.gov/cdrh_docs/pdf{YY}/{P_NUMBER}A.pdf` |
+| PMA SSED | `https://www.accessdata.fda.gov/cdrh_docs/pdf{YY}/{P_NUMBER}B.pdf` |
+| PMA supplement | `https://www.accessdata.fda.gov/cdrh_docs/pdf{YY}/{P_NUMBER}S{###}A.pdf` |
+
+Text extraction uses `pdfplumber` for machine-generated PDFs, with automatic OCR fallback via `pytesseract` + `pdf2image` for scanned documents.
+
+## License
+
+MIT

fda_mcp-0.1.0/README.md

@@ -0,0 +1,263 @@
+# FDA MCP Server
+
+An MCP (Model Context Protocol) server that provides LLM-optimized access to FDA data through the [OpenFDA API](https://open.fda.gov/) and direct FDA document retrieval. Covers all 21 OpenFDA endpoints plus regulatory decision documents (510(k) summaries, De Novo decisions, PMA approval letters).
+
+## Features
+
+- **12 MCP tools** covering drug, device, food, and other FDA data
+- **3 MCP resources** for query syntax help, endpoint reference, and field discovery
+- **All 21 OpenFDA endpoints** organized into 9 search tools by outcome, not endpoint
+- **FDA decision documents** — downloads and extracts text from 510(k) summaries, De Novo decisions, PMA approvals, SSEDs, and supplements
+- **OCR fallback** for scanned PDF documents (older FDA submissions)
+- **Context-efficient responses** — summarized output, field discovery on demand, pagination guidance
+- **Optional API key** support for higher rate limits
+
+## Tools
+
+### Search Tools (9)
+
+| Tool | Endpoints | Discriminator |
+|------|-----------|---------------|
+| `search_adverse_events` | drug/event, device/event, food/event | `product_type` |
+| `search_recalls` | drug/enforcement, device/enforcement, food/enforcement, device/recall | `product_type`, `source` |
+| `search_drug_labels` | drug/label | — |
+| `search_drugs` | drug/drugsfda, drug/ndc | `source` |
+| `search_drug_shortages` | drug/shortage | — |
+| `search_device_submissions` | device/510k, device/pma, device/classification, device/registrationlisting | `submission_type` |
+| `search_device_udi` | device/udi | — |
+| `search_substances` | other/substance, other/unii, other/nsde | `source` |
+| `search_other` | other/historicaldocument, device/covid19serology | `dataset` |
+
+All search tools accept `search` (OpenFDA query string), `limit`, `skip`, and `sort` parameters.
+
+### Cross-Cutting Tools (3)
+
+| Tool | Purpose |
+|------|---------|
+| `count_records` | Aggregation queries on any endpoint. Returns counts with percentages and narrative summary. |
+| `list_searchable_fields` | Returns searchable field names for any endpoint. Keeps field docs out of tool descriptions. |
+| `get_decision_document` | Fetches FDA regulatory decision PDFs and extracts text. Supports 510(k), De Novo, PMA, SSED, and supplement documents. |
+
+### Resources (3)
+
+| URI | Content |
+|-----|---------|
+| `fda://reference/query-syntax` | OpenFDA query syntax: AND/OR/NOT, wildcards, date ranges, exact matching |
+| `fda://reference/endpoints` | All 21 endpoints with descriptions |
+| `fda://reference/fields/{endpoint}` | Per-endpoint field reference |
+
+## Installation
+
+Requires Python 3.11+ and [uv](https://docs.astral.sh/uv/).
+
+```bash
+git clone <repo-url> fda-mcp
+cd fda-mcp
+uv sync
+```
+
+### Optional: OCR support for scanned PDFs
+
+Many older FDA documents (pre-2010) are scanned images. To extract text from these:
+
+```bash
+# macOS
+brew install tesseract poppler
+
+# Linux (Debian/Ubuntu)
+apt install tesseract-ocr poppler-utils
+```
+
+Without these, the server will still work — it returns a helpful message when it encounters a scanned document it can't read.
+
+## Usage with Claude Desktop
+
+Add to your `claude_desktop_config.json`:
+
+```json
+{
+  "mcpServers": {
+    "fda": {
+      "command": "uv",
+      "args": ["--directory", "/absolute/path/to/fda-mcp", "run", "fda-mcp"],
+      "env": {
+        "OPENFDA_API_KEY": "your-key-here"
+      }
+    }
+  }
+}
+```
+
+The `OPENFDA_API_KEY` is optional. Without it, you get 40 requests/minute. With a key (free from [open.fda.gov](https://open.fda.gov/apis/authentication/)), you get 240 requests/minute.
+
+### Config file location
+
+- **macOS**: `~/Library/Application Support/Claude/claude_desktop_config.json`
+- **Windows**: `%APPDATA%\Claude\claude_desktop_config.json`
+
+## Usage with Claude Code
+
+Add the server to your project's `.claude/settings.json` or global settings:
+
+```json
+{
+  "mcpServers": {
+    "fda": {
+      "command": "uv",
+      "args": ["--directory", "/absolute/path/to/fda-mcp", "run", "fda-mcp"],
+      "env": {
+        "OPENFDA_API_KEY": "your-key-here"
+      }
+    }
+  }
+}
+```
+
+Or add it interactively with `/mcp` in Claude Code.
+
+## Example Queries
+
+Once connected, you can ask Claude things like:
+
+- "Search for adverse events related to OZEMPIC"
+- "Find all Class I device recalls from 2024"
+- "What are the most common adverse reactions reported for LIPITOR?"
+- "Get the 510(k) summary for K213456"
+- "Search for PMA approvals for cardiovascular devices"
+- "How many drug recalls has Pfizer had? Break down by classification."
+- "Find the drug label for metformin and summarize the warnings"
+- "What COVID-19 serology tests has Abbott submitted?"
+
+## Configuration
+
+All configuration is via environment variables:
+
+| Variable | Default | Description |
+|----------|---------|-------------|
+| `OPENFDA_API_KEY` | *(none)* | API key for higher rate limits (240 vs 40 req/min) |
+| `OPENFDA_TIMEOUT` | `30` | HTTP request timeout in seconds |
+| `OPENFDA_MAX_CONCURRENT` | `4` | Max concurrent API requests |
+| `FDA_PDF_TIMEOUT` | `60` | PDF download timeout in seconds |
+| `FDA_PDF_MAX_LENGTH` | `8000` | Default max text characters extracted from PDFs |
+
+## OpenFDA Query Syntax
+
+The `search` parameter on all tools uses OpenFDA query syntax:
+
+```
+# AND
+patient.drug.openfda.brand_name:"ASPIRIN"+AND+serious:1
+
+# OR (space = OR)
+brand_name:"ASPIRIN" brand_name:"IBUPROFEN"
+
+# NOT
+NOT+classification:"Class III"
+
+# Date ranges
+decision_date:[20230101+TO+20231231]
+
+# Wildcards (trailing only, min 2 chars)
+device_name:pulse*
+
+# Exact matching (required for count queries)
+patient.reaction.reactionmeddrapt.exact:"Nausea"
+```
+
+Use `list_searchable_fields` or the `fda://reference/query-syntax` resource for the full reference.
+
+## Development
+
+```bash
+# Install with dev dependencies
+uv sync --all-extras
+
+# Run unit tests (157 tests, no network)
+uv run pytest
+
+# Run integration tests (hits real FDA API)
+OPENFDA_TIMEOUT=60 uv run pytest -m integration
+
+# Run a specific test file
+uv run pytest tests/test_endpoints.py -v
+
+# Start the server directly
+uv run fda-mcp
+```
+
+### Project Structure
+
+```
+src/fda_mcp/
+├── server.py              # FastMCP server entry point
+├── config.py              # Environment-based configuration
+├── errors.py              # Custom error types
+├── openfda/
+│   ├── endpoints.py       # Enum of all 21 endpoints
+│   ├── client.py          # Async HTTP client with rate limiting
+│   └── summarizer.py      # Response summarization per endpoint
+├── documents/
+│   ├── urls.py            # FDA document URL construction
+│   └── fetcher.py         # PDF download + text extraction + OCR
+├── tools/
+│   ├── search.py          # 9 search tool handlers
+│   ├── count.py           # count_records tool
+│   ├── fields.py          # list_searchable_fields tool
+│   └── decision_documents.py
+└── resources/
+    ├── query_syntax.py    # Query syntax reference
+    ├── endpoints_resource.py
+    └── field_definitions.py
+```
+
+### Test Structure
+
+```
+tests/
+├── test_endpoints.py                    # Endpoint enum
+├── test_openfda_client.py               # HTTP client
+├── test_summarizer.py                   # Response summarizers (21 endpoints)
+├── test_document_urls.py                # URL construction
+├── test_document_fetcher.py             # PDF extraction + OCR
+├── test_tool_search_*.py                # 9 search tool test files
+├── test_tool_count_records.py           # Count tool
+├── test_tool_list_fields.py             # Fields tool
+├── test_tool_decision_documents.py      # Document tool
+├── test_resources.py                    # MCP resources
+├── test_error_handling.py               # Error cases
+└── integration/
+    ├── test_live_openfda.py             # Live API (21 endpoints)
+    └── test_live_documents.py           # Live PDF fetch
+```
+
+## How It Works
+
+### Context Efficiency
+
+The server is designed to minimize context window usage when used by LLMs:
+
+1. **Response summarization** — Each endpoint type has a custom summarizer that extracts key fields and flattens nested structures. Drug labels truncate sections to 2,000 chars. PDF text defaults to 8,000 chars.
+
+2. **Field discovery via tool** — Instead of listing all searchable fields in tool descriptions (which would cost ~8,000-11,000 tokens of persistent context), the `list_searchable_fields` tool provides them on demand.
+
+3. **Smart pagination** — Default page sizes are low (10 records). Responses include `total_results`, `showing`, and `has_more`. When results exceed 100, a tip suggests using `count_records` for aggregation.
+
+4. **Count enrichment** — `count_records` returns values with pre-calculated percentages and a one-sentence narrative summary.
+
+### FDA Decision Documents
+
+These documents are **not** available through the OpenFDA API. The server constructs URLs and fetches directly from `accessdata.fda.gov`:
+
+| Document Type | URL Pattern |
+|--------------|-------------|
+| 510(k) summary | `https://www.accessdata.fda.gov/cdrh_docs/reviews/{K_NUMBER}.pdf` |
+| De Novo decision | `https://www.accessdata.fda.gov/cdrh_docs/reviews/{DEN_NUMBER}.pdf` |
+| PMA approval | `https://www.accessdata.fda.gov/cdrh_docs/pdf{YY}/{P_NUMBER}A.pdf` |
+| PMA SSED | `https://www.accessdata.fda.gov/cdrh_docs/pdf{YY}/{P_NUMBER}B.pdf` |
+| PMA supplement | `https://www.accessdata.fda.gov/cdrh_docs/pdf{YY}/{P_NUMBER}S{###}A.pdf` |
+
+Text extraction uses `pdfplumber` for machine-generated PDFs, with automatic OCR fallback via `pytesseract` + `pdf2image` for scanned documents.
+
+## License
+
+MIT