FDA Device Establishment Registration — Bulk Supplier Qualification Lookup

Look up FDA device establishment registration records in bulk. Give this Actor a list of suppliers, contract manufacturers, contract sterilizers, repackagers, specification developers or importers, and it returns each firm's FDA device establishment registration, its status, its establishment types and every device it has listed.

Built for the supplier-qualification and regulatory-intelligence job: "are all 300 firms on our approved supplier list currently registered with FDA, and for what?" — answered in one run instead of 300 manual searches in the FDA Establishment Registration & Device Listing database.

Data source: the openFDA device/registrationlisting endpoint — the FDA's own public, versioned, documented API. US Government work, public domain. No scraping, no CAPTCHAs, no HTML parsing that silently breaks.

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What it does

For each supplier you supply, the Actor:

1. Looks the firm up by registration number, FEI number or owner / operator number if you have one — these are unambiguous.
2. Falls back to the exact legal name as filed with FDA.
3. Falls back again to a token search with local similarity scoring, and reports the result as a potential match only.
4. Returns every matching establishment with its registration status, address, US agent, owner/operator, establishment types and listed device products (product code, device name, device class, 21 CFR regulation number, medical specialty, K-number / PMA number where present).

Why the output is graded rather than a yes/no

A firm's registered legal name is very often not the name on your purchase order — MEDTRONIC, INC. vs Medtronic, or a transliterated foreign establishment name. Reporting "not registered" because a string did not match would disqualify a legitimate supplier.

So this Actor only sets registered: true on an identifier-grade or exact-name match with an active registration. Everything else is returned with requiresManualVerification: true and guidance explaining what the result does and does not mean. If openFDA is unreachable or rate-limits the run, the Actor fails loudly rather than reporting everyone as unregistered.

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Input

{
  "suppliers": [
    { "supplierId": "SUP-001", "firmName": "MEDTRONIC, INC." },
    { "supplierId": "SUP-002", "registrationNumber": "2124215" },
    { "supplierId": "SUP-003", "feiNumber": "2182208" },
    { "supplierId": "SUP-004", "ownerOperatorNumber": "2112641" }
  ],
  "fuzzyThreshold": 0.5,
  "maxEstablishmentsPerSupplier": 10,
  "openFdaApiKey": ""
}

Field	Type	Default	Meaning
suppliers	array	required	One object per firm. Any combination of firmName, registrationNumber, feiNumber, ownerOperatorNumber. Extra fields (supplierId, your internal keys) are echoed back in input.
fuzzyThreshold	number	0.5	Minimum token-overlap similarity for a name-only match to be reported at all. Raise it to cut noise, lower it to widen the net.
maxEstablishmentsPerSupplier	number	10	Cap on establishments returned per supplier. Large corporations have hundreds of registered sites.
maxRowsPerQuery	number	1000	Cap on raw openFDA rows fetched per lookup.
openFdaApiKey	string	""	Optional. Anonymous openFDA access is capped at 1,000 requests/day per IP; a free openFDA key raises that to 120,000/day. Recommended for lists over ~200 suppliers.

Output

One dataset item per supplier:

{
  "input": { "supplierId": "SUP-001", "firmName": "MEDTRONIC, INC." },
  "screenedAt": "2026-07-29T05:00:00+00:00",
  "dataLastUpdated": "2026-07-20",
  "matchType": "name_exact",
  "matchCount": 3,
  "registered": true,
  "activeRegistrationCount": 3,
  "requiresManualVerification": false,
  "guidance": "Identifier-grade match: 3 active FDA device establishment registration(s) found.",
  "establishments": [
    {
      "registrationNumber": "2182208",
      "feiNumber": "2182208",
      "firmName": "MEDTRONIC, INC.",
      "statusCode": "1",
      "registrationActive": true,
      "registrationExpiryYear": "2026",
      "initialImporter": false,
      "establishmentTypes": ["Manufacture Medical Device"],
      "address": { "city": "MINNEAPOLIS", "stateCode": "MN", "countryCode": "US" },
      "ownerOperator": { "number": "2112641", "firmName": "Medtronic, Inc." },
      "usAgent": null,
      "listedProductCount": 42,
      "listedProducts": [
        {
          "productCode": "LWP",
          "deviceName": "Pacemaker, Permanent, Implantable",
          "deviceClass": "3",
          "regulationNumber": "870.3610",
          "medicalSpecialty": "Cardiovascular"
        }
      ]
    }
  ]
}

matchType is one of registration_number_exact, fei_number_exact, owner_operator_exact, name_exact, name_fuzzy, none — in descending order of confidence.

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Typical uses

• Supplier qualification — confirm every firm on an approved supplier list holds a current FDA device establishment registration, on a recurring schedule.
• Contract manufacturer / contract sterilizer due diligence — the establishmentTypes field tells you what the site is actually registered to do, not just that it is registered.
• Import readiness — check the initialImporter flag and the US agent on record for foreign establishments.
• Competitive and market intelligence — pull every establishment listing a given product code or operating in a given country.
• M&A and audit prep — reconcile a target's claimed registrations against FDA's own file.

Notes and limits

• This is the device establishment registration file. Drug establishment registration is a different FDA dataset.
• Registration is not clearance or approval. A registered establishment may still list devices under exemptions; check listedProducts[].exempt, kNumber and pmaNumber.
• Registration data is a snapshot — check dataLastUpdated in every item for the vintage of the file you were served.
• openFDA's own disclaimer applies: do not rely on it for decisions regarding medical care. For a regulatory decision, confirm against FDA's Establishment Registration & Device Listing database.