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 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

{
    "medicalSpecialty": "Cardiovascular",
    "maxResults": 500
}

Expected output: 400–500 cardiovascular device classifications.

Input Example 2: All Class II Dental Devices

{
    "deviceClass": "2",
    "medicalSpecialty": "Dental",
    "maxResults": 1000
}

Expected output: 100–200 Class II dental devices.

Input Example 3: Empty Input (Full Database)

{}

Expected output: 7,000+ all device classifications.

Output Example

[
    {
        "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 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, 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
• 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.

Other Apify Actors

Check out related Actors for additional medical/regulatory data:

• CISA Known Exploited Vulnerabilities Scraper — CVE threat intelligence
• Google Maps Business Scraper — Healthcare provider locations
• LinkedIn Profile Scraper — 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.

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Version: 0.1
Author: seatsignal
Last Updated: 2026-06-18
Data Source: openFDA Device Classification API