# US FDA Compliance Monitor (`great_pistachio/us-fda-compliance-monitor`) Actor Monitor the FDA for medical device recalls, 510(k) clearances, PMA approvals, and drug/food enforcement actions, from the official openFDA API. Filter by firm, product, or keyword and date. For regulatory affairs, compliance teams, and competitive intelligence. - **URL**: https://apify.com/great\_pistachio/us-fda-compliance-monitor.md - **Developed by:** [Saturnin Pugnet](https://apify.com/great_pistachio) (community) - **Categories:** Other - **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks - **User rating**: No ratings yet ## Pricing from $20.00 / 1,000 results This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events. Learn more: https://docs.apify.com/platform/actors/running/actors-in-store#pay-per-event ## What's an Apify Actor? Actors are web data automations that power AI and operations. They run on the Apify platform to scrape websites, process data, connect APIs, and automate workflows. In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours, and optionally produces a well-defined JSON output, datasets with results, or files in key-value store. In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server. Actors are written with capital "A". ## How to integrate an Actor? If asked about integration, you help developers integrate Actors into their projects. You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready. The best way to integrate Actors is as follows. In JavaScript/TypeScript projects, use official [JavaScript/TypeScript client](https://docs.apify.com/api/client/js/docs.md): ```bash npm install apify-client ``` In Python projects, use official [Python client library](https://docs.apify.com/api/client/python/docs.md): ```bash pip install apify-client ``` In shell scripts, use [Apify CLI](https://docs.apify.com/cli/docs.md): ````bash # MacOS / Linux curl -fsSL https://apify.com/install-cli.sh | bash # Windows irm https://apify.com/install-cli.ps1 | iex ```bash In AI frameworks, you might use the [Apify MCP server](https://docs.apify.com/integrations/mcp.md). If your project is in a different language, use the [REST API](https://docs.apify.com/api/v2.md). For usage examples, see the [API](#api) section below. For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt). # README ## US FDA Compliance Monitor Monitor the FDA for the regulatory events that matter, in one unified feed from the official [openFDA](https://open.fda.gov) API: - **Medical device recalls** — who's recalling what, and why - **510(k) clearances** — new devices cleared to market (competitor launch intel) - **PMA approvals** — premarket approvals and supplements - **Drug enforcement / recalls** — Class I/II/III drug recalls - **Food enforcement / recalls** — food safety recalls (allergens, contamination) Filter by firm, product, or keyword and a date window. Runs as a lightweight HTTP actor — fast and cheap. ### Who Uses This - **Medtech / pharma regulatory affairs**: track recalls and enforcement across your product codes - **Compliance teams**: get alerted to Class I recalls and enforcement actions in your category - **Competitive intelligence**: 510(k)/PMA feeds show exactly when competitors get a device cleared - **Food & beverage safety**: monitor allergen and contamination recalls - **AI agents**: ask "recent recalls for [firm]", "510(k) clearances this month in [category]", "Class I food recalls with allergen X" ### Input ```json { "dataTypes": ["device-recalls", "device-510k"], "searchTerm": "", "sinceDays": 90, "maxResultsPerType": 0 } ```` | Field | Description | |-------|-------------| | `dataTypes` | Which FDA datasets to pull (empty = all): `device-recalls`, `device-510k`, `device-pma`, `drug-enforcement`, `food-enforcement` | | `searchTerm` | Optional keyword filter (firm, product, reason) | | `sinceDays` | Only records from the last N days | | `maxResultsPerType` / `maxResults` | Caps (0 = unlimited) | ### Output Unified schema across all datasets: `dataType`, `signalDate`, `firm`, `productName`, `classification` (e.g. Class I), `status`, `reason`, `productCode`, `idNumber` (recall/K/PMA number), `advisoryCommittee`, `state`, `country`, `distributionPattern`, `sourceUrl`, `dataSource`. ### Notes - Data comes from the official openFDA API. It refreshes every few days (device recalls and 510(k)s are typically current within a week). - Drug/food enforcement report\_date and device event/decision dates drive the date window per dataset. - Schedule a daily/weekly run to keep a live compliance feed; combine with webhooks for alerts. ### Related Actors - [US Business Entity Search](https://apify.com/great_pistachio/us-business-search) - Verify a recalling firm's business registration - [Website Company Enricher](https://apify.com/great_pistachio/website-company-enricher) - Enrich a firm with contact and company data # Actor input Schema ## `dataTypes` (type: `array`): Which FDA datasets to pull. Leave empty for all. ## `searchTerm` (type: `string`): Optional keyword to filter by (firm name, product, reason, etc.). Leave empty for everything in the window. ## `sinceDays` (type: `integer`): Only include records from the last N days. ## `maxResultsPerType` (type: `integer`): Cap per dataset. 0 = unlimited. ## `maxResults` (type: `integer`): Cap total across all datasets. 0 = unlimited. ## Actor input object example ```json { "dataTypes": [], "searchTerm": "", "sinceDays": 90, "maxResultsPerType": 0, "maxResults": 0 } ``` # Actor output Schema ## `defaultDataset` (type: `string`): FDA device recalls, 510(k) clearances, PMA approvals, and drug/food enforcement actions with firm, product, classification, reason, and date # API You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup. ## JavaScript example ```javascript import { ApifyClient } from 'apify-client'; // Initialize the ApifyClient with your Apify API token // Replace the '' with your token const client = new ApifyClient({ token: '', }); // Prepare Actor input const input = {}; // Run the Actor and wait for it to finish const run = await client.actor("great_pistachio/us-fda-compliance-monitor").call(input); // Fetch and print Actor results from the run's dataset (if any) console.log('Results from dataset'); console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`); const { items } = await client.dataset(run.defaultDatasetId).listItems(); items.forEach((item) => { console.dir(item); }); // 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs ``` ## Python example ```python from apify_client import ApifyClient # Initialize the ApifyClient with your Apify API token # Replace '' with your token. client = ApifyClient("") # Prepare the Actor input run_input = {} # Run the Actor and wait for it to finish run = client.actor("great_pistachio/us-fda-compliance-monitor").call(run_input=run_input) # Fetch and print Actor results from the run's dataset (if there are any) print("💾 Check your data here: https://console.apify.com/storage/datasets/" + run["defaultDatasetId"]) for item in client.dataset(run["defaultDatasetId"]).iterate_items(): print(item) # 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start ``` ## CLI example ```bash echo '{}' | apify call great_pistachio/us-fda-compliance-monitor --silent --output-dataset ``` ## MCP server setup ```json { "mcpServers": { "apify": { "command": "npx", "args": [ "mcp-remote", "https://mcp.apify.com/?tools=great_pistachio/us-fda-compliance-monitor", "--header", "Authorization: Bearer " ] } } } ``` ## OpenAPI specification ```json { "openapi": "3.0.1", "info": { "title": "US FDA Compliance Monitor", "description": "Monitor the FDA for medical device recalls, 510(k) clearances, PMA approvals, and drug/food enforcement actions, from the official openFDA API. Filter by firm, product, or keyword and date. For regulatory affairs, compliance teams, and competitive intelligence.", "version": "1.0", "x-build-id": "8rmcKsg3dq9rNtdc5" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/great_pistachio~us-fda-compliance-monitor/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-great_pistachio-us-fda-compliance-monitor", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for its completion, and returns Actor's dataset items in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } }, "/acts/great_pistachio~us-fda-compliance-monitor/runs": { "post": { "operationId": "runs-sync-great_pistachio-us-fda-compliance-monitor", "x-openai-isConsequential": false, "summary": "Executes an Actor and returns information about the initiated run in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/runsResponseSchema" } } } } } } }, "/acts/great_pistachio~us-fda-compliance-monitor/run-sync": { "post": { "operationId": "run-sync-great_pistachio-us-fda-compliance-monitor", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } } }, "components": { "schemas": { "inputSchema": { "type": "object", "required": [ "sinceDays" ], "properties": { "dataTypes": { "title": "Data Types", "uniqueItems": true, "type": "array", "description": "Which FDA datasets to pull. Leave empty for all.", "items": { "type": "string", "enum": [ "device-recalls", "device-510k", "device-pma", "drug-enforcement", "food-enforcement" ], "enumTitles": [ "Medical Device Recalls", "Device 510(k) Clearances", "Device PMA Approvals", "Drug Enforcement / Recalls", "Food Enforcement / Recalls" ] }, "default": [] }, "searchTerm": { "title": "Search Term", "type": "string", "description": "Optional keyword to filter by (firm name, product, reason, etc.). Leave empty for everything in the window.", "default": "" }, "sinceDays": { "title": "Since (days)", "minimum": 1, "maximum": 3650, "type": "integer", "description": "Only include records from the last N days.", "default": 90 }, "maxResultsPerType": { "title": "Max Results per Data Type", "minimum": 0, "type": "integer", "description": "Cap per dataset. 0 = unlimited.", "default": 0 }, "maxResults": { "title": "Max Results Total", "minimum": 0, "type": "integer", "description": "Cap total across all datasets. 0 = unlimited.", "default": 0 } } }, "runsResponseSchema": { "type": "object", "properties": { "data": { "type": "object", "properties": { "id": { "type": "string" }, "actId": { "type": "string" }, "userId": { "type": "string" }, "startedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "finishedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "status": { "type": "string", "example": "READY" }, "meta": { "type": "object", "properties": { "origin": { "type": "string", "example": "API" }, "userAgent": { "type": "string" } } }, "stats": { "type": "object", "properties": { "inputBodyLen": { "type": "integer", "example": 2000 }, "rebootCount": { "type": "integer", "example": 0 }, "restartCount": { "type": "integer", "example": 0 }, "resurrectCount": { "type": "integer", "example": 0 }, "computeUnits": { "type": "integer", "example": 0 } } }, "options": { "type": "object", "properties": { "build": { "type": "string", "example": "latest" }, "timeoutSecs": { "type": "integer", "example": 300 }, "memoryMbytes": { "type": "integer", "example": 1024 }, "diskMbytes": { "type": "integer", "example": 2048 } } }, "buildId": { "type": "string" }, "defaultKeyValueStoreId": { "type": "string" }, "defaultDatasetId": { "type": "string" }, "defaultRequestQueueId": { "type": "string" }, "buildNumber": { "type": "string", "example": "1.0.0" }, "containerUrl": { "type": "string" }, "usage": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "integer", "example": 1 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } }, "usageTotalUsd": { "type": "number", "example": 0.00005 }, "usageUsd": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "number", "example": 0.00005 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } } } } } } } } } ```