# FDA Medical Device Classification Database Scraper (`compute-edge/fda-device-classification-scraper`) Actor Extract FDA medical device classification entries from openFDA. Get product codes, device names, device class (I, II, III), regulation numbers, medical specialty, and regulatory flags. Filter by device class, medical specialty, product code, or regulation number. - **URL**: https://apify.com/compute-edge/fda-device-classification-scraper.md - **Developed by:** [Compute Edge](https://apify.com/compute-edge) (community) - **Categories:** Lead generation - **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks - **User rating**: No ratings yet ## Pricing from $3.00 / 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 a software tools running on the Apify platform, for all kinds of web data extraction and automation use cases. 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.md): ```bash npm install apify-client ``` In Python projects, use official [Python client library](https://docs.apify.com/api/client/python.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/platform/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 ## FDA Medical Device Classification Database Scraper ### Overview This Actor extracts comprehensive medical device classification data from the **openFDA Device Classification database**. The FDA maintains this authoritative registry of all approved and cleared medical devices, including product codes, device names, regulatory classifications, and medical specialty information. This scraper enables developers, regulatory professionals, and healthcare researchers to programmatically access and analyze the entire FDA device classification database. ### What Does It Do? The FDA Device Classification Scraper retrieves device classification entries from openFDA (the FDA's public API), with optional filtering by: - **Device Class** (1, 2, 3, or Unclassified) - **Medical Specialty** (e.g., Cardiovascular, Dental, Orthopedic) - **Product Code** (e.g., KMT, DVL, DHE) - **Regulation Number** (e.g., 872.6870) Each record includes: - Product code and device name - Device classification level (Class 1/2/3/U/N) - Medical specialty category and description - Regulatory information (regulation number, review panel) - GMP exemption status, implantability, and life-sustaining support flags - Submission type and malfunction reporting eligibility **Total Coverage**: 7,000+ medical device classifications across all regulated device types. ### Why Use This Actor? #### Regulatory Compliance - Stay current with FDA device classifications - Identify regulatory pathways for new medical devices - Verify device classification requirements before market entry #### Market Research - Identify competitors in specific medical specialties - Map the landscape of devices in your category - Analyze device class distribution by specialty #### AI Training Data - Rich structured data suitable for ML training on medical device characteristics - Balanced dataset covering all device classes and specialties - Metadata suitable for regulatory AI applications #### Healthcare & Regulatory Professionals - Build custom device registries for organizational needs - Export compliance documentation - Integrate FDA data into ERP/CMS systems ### Output Fields | Field | Type | Description | |-------|------|-------------| | productCode | string | Unique FDA product code (e.g., "KMT") | | deviceName | string | Official FDA device name | | deviceClass | string | Classification level: "1" (low risk), "2" (moderate), "3" (high), "U" (unclassified), "N" (not classified) | | medicalSpecialty | string | Two-letter medical specialty code (e.g., "DE") | | medicalSpecialtyDescription | string | Human-readable specialty name (e.g., "Dental") | | regulationNumber | string | CFR reference (e.g., "872.6870") | | definition | string | FDA device definition (truncated to 500 characters) | | reviewPanel | string | Regulatory review panel assigned | | submissionTypeId | string | Submission type ID | | gmpExempt | boolean | Good Manufacturing Practices exemption status | | thirdPartyEligible | boolean | Eligible for third-party review | | lifeSustainSupport | boolean | Life-sustaining or life-supporting device | | implantable | boolean | Implantable device flag | | summaryMalfunctionReporting | string | Malfunction reporting requirements | ### Input Parameters #### Device Class Filter Filter by regulatory classification level. Leave empty to include all classes. - `1` = Class I (General Controls) - `2` = Class II (Special Controls) - `3` = Class III (Premarket Approval) - `U` = Unclassified - `N` = Not Classified **Example**: `"2"` returns only Class II devices. #### Medical Specialty Filter Filter by medical specialty description. Case-sensitive. **Examples**: - `"Cardiovascular"` — heart/vessel devices - `"Dental"` — dental devices - `"Orthopedic"` — bone/joint devices #### Product Code Filter Filter by FDA product code (case-sensitive). **Examples**: - `"KMT"` — Tray, fluoride, disposable - `"DVL"` — Gauze, cotton, sterile - `"DHE"` — Dental handpiece #### Regulation Number Filter Filter by Code of Federal Regulations (CFR) reference. **Example**: `"872.6870"` for dental devices. #### Max Results Maximum classifications to return (1–25,000). Default: 1,000. ### Tutorial: How to Scrape the FDA Device Classification Database #### Step 1: Navigate to the Actor Visit the [Actor](https://console.apify.com) or add it to your account. #### Step 2: Set Filters (Optional) For **all 7,000+ classifications**, leave all filters blank and click **Start**. For **specific subsets**, fill in filters: - To find all cardiovascular devices: set `medicalSpecialty` to `"Cardiovascular"` - To find Class III (high-risk) devices: set `deviceClass` to `"3"` - To find implantable orthopedic devices: set `medicalSpecialty` to `"Orthopedic"` and filter code-by-code #### Step 3: Monitor Execution The Actor will: 1. Connect to the openFDA API 2. Paginate through results (1,000 per page) 3. Transform and normalize device records 4. Push data to the default dataset Typical execution time: 10–30 seconds for full database, 2–5 seconds for filtered subsets. #### Step 4: Download Results Once complete, download your dataset as: - **CSV** (for Excel/Sheets) - **JSON** (for APIs/databases) - **JSONL** (for streaming) - **XML** (for legacy systems) #### Example: Export Cardiovascular Device Registrations 1. Set `medicalSpecialty` = `"Cardiovascular"` 2. Set `maxResults` = `1000` 3. Click **Start** 4. Wait ~5 seconds 5. Download CSV 6. Import into your CMS/CRM ### Pricing The FDA Device Classification Scraper uses **per-result pricing**: - **$0.003 per device classification** extracted - **Actor startup**: $0.00005 (one-time per run) - **Apify compute**: Additional charge based on memory/CPU usage #### Cost Examples - Full database (7,000 classifications): ~$0.021 + compute - Filtered subset (500 classifications): ~$0.0015 + compute - Monthly job (20 runs, 200 results/run): ~$0.012 + compute **Total monthly cost for active users**: Usually $0.50–$2.00. ### Input/Output Examples #### Input Example 1: All Cardiovascular Devices ```json { "medicalSpecialty": "Cardiovascular", "maxResults": 500 } ```` **Expected output**: 400–500 cardiovascular device classifications. #### Input Example 2: All Class II Dental Devices ```json { "deviceClass": "2", "medicalSpecialty": "Dental", "maxResults": 1000 } ``` **Expected output**: 100–200 Class II dental devices. #### Input Example 3: Empty Input (Full Database) ```json {} ``` **Expected output**: 7,000+ all device classifications. #### Output Example ```json [ { "productCode": "KMT", "deviceName": "Tray, Fluoride, Disposable", "deviceClass": "1", "medicalSpecialty": "DE", "medicalSpecialtyDescription": "Dental", "regulationNumber": "872.6870", "definition": "", "reviewPanel": "DE", "submissionTypeId": "4", "gmpExempt": true, "thirdPartyEligible": false, "lifeSustainSupport": false, "implantable": false, "summaryMalfunctionReporting": "Eligible" }, { "productCode": "DVL", "deviceName": "Gauze, Cotton, Sterile", "deviceClass": "1", "medicalSpecialty": "SU", "medicalSpecialtyDescription": "Surgery", "regulationNumber": "878.4020", "definition": "Surgical gauze used for wound management.", "reviewPanel": "SU", "submissionTypeId": "4", "gmpExempt": true, "thirdPartyEligible": false, "lifeSustainSupport": false, "implantable": false, "summaryMalfunctionReporting": "Not Eligible" } ] ``` ### FAQ #### Q: Is this data real-time? **A**: openFDA updates monthly. This Actor fetches the latest published data from the FDA database. For production regulatory systems, verify against [FDA's official portal](https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances) for critical decisions. #### Q: Can I filter by multiple medical specialties? **A**: The current version filters by a single specialty. To retrieve multiple specialties, run the Actor once per specialty and merge the results, or request a custom configuration. #### Q: What does "GMP Exempt" mean? **A**: Good Manufacturing Practice (GMP) exemption applies to Class I devices with minimal regulatory burden. GMP-exempt devices are typically low-risk (e.g., bandages, tongue depressors). #### Q: Can I use this data commercially? **A**: openFDA data is public domain. You may use it for commercial purposes, but see the Legal Disclaimer section. #### Q: How often should I re-run this Actor? **A**: For compliance purposes, quarterly or after FDA announcements. For market research, annual updates are typical. #### Q: What if I get fewer results than expected? **A**: Verify your filter spelling is exact (filters are case-sensitive for medical specialty and product code). Try running with empty filters to see total available records. ### Legal Disclaimer #### Data Source & License This Actor retrieves data from the [openFDA API](https://open.fda.gov/), a public-domain dataset maintained by the U.S. Food and Drug Administration. All openFDA data is in the public domain and available for unrestricted use. #### Disclaimer of Medical/Regulatory Advice **This Actor provides informational data only.** The FDA Device Classification Scraper does not provide medical advice, regulatory guidance, or legal counsel. For regulatory decisions: - Consult the [FDA's official Device Classification database](https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances) - Contact an FDA regulatory consultant - Review official device approvals/clearances before market entry #### Accuracy & Timeliness While we strive for accuracy, openFDA data is provided "as-is" without warranty. The FDA recommends treating all data as unvalidated until cross-referenced with official FDA systems. #### Acceptable Use This Actor may be used to: - Extract device classification data for research - Build compliance tools - Analyze FDA device trends - Inform regulatory strategy This Actor must NOT be used to: - Fraudulently represent non-approved devices as FDA-approved - Bypass FDA regulatory pathways - Misuse device data for deception For questions about FDA regulations, visit [fda.gov](https://www.fda.gov/medical-devices/). ### Other Apify Actors Check out related Actors for additional medical/regulatory data: - **[CISA Known Exploited Vulnerabilities Scraper](https://console.apify.com)** — CVE threat intelligence - **[Google Maps Business Scraper](https://console.apify.com)** — Healthcare provider locations - **[LinkedIn Profile Scraper](https://console.apify.com)** — Healthcare professional profiles ### Support & Troubleshooting #### Actor fails with timeout - The FDA API is slow for large queries. Reduce `maxResults` or add more specific filters. #### No results returned - Verify filter spelling (case-sensitive for medical specialty) - Try with empty filters to confirm data access - Check the Actor logs for detailed API errors #### Need custom modifications? - Contact support or request a custom build for additional filtering, field transformations, or integrations. *** **Version**: 0.1\ **Author**: seatsignal\ **Last Updated**: 2026-06-18\ **Data Source**: [openFDA Device Classification API](https://open.fda.gov/apis/device/classification/) # Actor input Schema ## `deviceClass` (type: `string`): Filter by device class (1, 2, 3, U, or N). Leave empty for all. Example: '2'. ## `medicalSpecialty` (type: `string`): Filter by medical specialty description (case-sensitive). Examples: 'Cardiovascular', 'Dental', 'Orthopedic'. ## `productCode` (type: `string`): Filter by product code (case-sensitive). Examples: 'KMT', 'DVL', 'DHE'. ## `regulationNumber` (type: `string`): Filter by regulation number. Example: '872.6870'. ## `maxResults` (type: `integer`): Maximum number of classification records to return. Default 1000, maximum 25000. ## Actor input object example ```json { "deviceClass": "", "medicalSpecialty": "", "productCode": "", "regulationNumber": "", "maxResults": 1000 } ``` # Actor output Schema ## `dataset` (type: `string`): No description # 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("compute-edge/fda-device-classification-scraper").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("compute-edge/fda-device-classification-scraper").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 compute-edge/fda-device-classification-scraper --silent --output-dataset ``` ## MCP server setup ```json { "mcpServers": { "apify": { "command": "npx", "args": [ "mcp-remote", "https://mcp.apify.com/?tools=compute-edge/fda-device-classification-scraper", "--header", "Authorization: Bearer " ] } } } ``` ## OpenAPI specification ```json { "openapi": "3.0.1", "info": { "title": "FDA Medical Device Classification Database Scraper", "description": "Extract FDA medical device classification entries from openFDA. Get product codes, device names, device class (I, II, III), regulation numbers, medical specialty, and regulatory flags. Filter by device class, medical specialty, product code, or regulation number.", "version": "0.1", "x-build-id": "IReZ4o8UedJRH6gKe" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/compute-edge~fda-device-classification-scraper/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-compute-edge-fda-device-classification-scraper", "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": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } }, "/acts/compute-edge~fda-device-classification-scraper/runs": { "post": { "operationId": "runs-sync-compute-edge-fda-device-classification-scraper", "x-openai-isConsequential": false, "summary": "Executes an Actor and returns information about the initiated run in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$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": { "$ref": "#/components/schemas/runsResponseSchema" } } } } } } }, "/acts/compute-edge~fda-device-classification-scraper/run-sync": { "post": { "operationId": "run-sync-compute-edge-fda-device-classification-scraper", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$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", "properties": { "deviceClass": { "title": "Device Class Filter", "type": "string", "description": "Filter by device class (1, 2, 3, U, or N). Leave empty for all. Example: '2'.", "default": "" }, "medicalSpecialty": { "title": "Medical Specialty Filter", "type": "string", "description": "Filter by medical specialty description (case-sensitive). Examples: 'Cardiovascular', 'Dental', 'Orthopedic'.", "default": "" }, "productCode": { "title": "Product Code Filter", "type": "string", "description": "Filter by product code (case-sensitive). Examples: 'KMT', 'DVL', 'DHE'.", "default": "" }, "regulationNumber": { "title": "Regulation Number Filter", "type": "string", "description": "Filter by regulation number. Example: '872.6870'.", "default": "" }, "maxResults": { "title": "Max Results", "minimum": 1, "maximum": 25000, "type": "integer", "description": "Maximum number of classification records to return. Default 1000, maximum 25000.", "default": 1000 } } }, "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 } } } } } } } } } } ```