{
  "_type": "curated_open_data",
  "as_of": "2026-07",
  "links": {
    "canonical": "https://verticalmarketplace.ai",
    "docs_for_llms": "https://verticalmarketplace.ai/llms.txt",
    "sell_your_own": "https://verticalmarketplace.ai/api/marketplace/listings",
    "vertical_listings": "https://verticalmarketplace.ai/api/marketplace/listings?vertical=medical-devices"
  },
  "records": [
    {
      "term": "Product code",
      "category": "identifiers",
      "reference": "Assigned in the Product Classification database",
      "definition": "A three-letter FDA code identifying the generic category of a device"
    },
    {
      "term": "Regulation number",
      "category": "regulation",
      "reference": "Ties a product code to its rule",
      "definition": "The 21 CFR citation that defines a device type and its class"
    },
    {
      "term": "Global Medical Device Nomenclature (GMDN)",
      "category": "classification",
      "reference": "Used in UDI submissions",
      "definition": "An international system of terms naming and grouping medical devices"
    },
    {
      "term": "Unique Device Identification (UDI)",
      "category": "identifiers",
      "reference": "Combines a device identifier and production identifier",
      "definition": "A code that identifies a device through distribution and use"
    },
    {
      "term": "Predicate device",
      "category": "regulation",
      "reference": "Anchor for substantial equivalence",
      "definition": "A legally marketed device used as the comparison basis in a 510(k)"
    },
    {
      "term": "Substantial equivalence",
      "category": "regulation",
      "reference": "The 510(k) clearance standard",
      "definition": "A finding that a new device is as safe and effective as a predicate"
    },
    {
      "term": "Medical Device Reporting (MDR)",
      "category": "safety",
      "reference": "Feeds the MAUDE database",
      "definition": "Mandatory reporting of device-related deaths, serious injuries, and malfunctions"
    },
    {
      "term": "MAUDE",
      "category": "safety",
      "reference": "Includes voluntary and mandatory reports",
      "definition": "The FDA database of adverse-event reports involving medical devices"
    },
    {
      "term": "Instructions for Use (IFU)",
      "category": "quality",
      "reference": "Part of device labeling",
      "definition": "The manufacturer's directions for safe and effective device use"
    },
    {
      "term": "Quality Management System Regulation (QMSR)",
      "category": "quality",
      "reference": "Aligned with ISO 13485 effective February 2, 2026",
      "definition": "FDA quality-system requirements for device makers under 21 CFR Part 820"
    },
    {
      "term": "ISO 13485",
      "category": "quality",
      "reference": "Widely referenced in device manufacturing",
      "definition": "The international quality-management standard for medical devices"
    },
    {
      "term": "Device classes I, II, and III",
      "category": "classification",
      "reference": "Higher class means higher risk and oversight",
      "definition": "Risk-based classification determining regulatory controls"
    },
    {
      "term": "Global UDI Database (GUDID)",
      "category": "identifiers",
      "reference": "Public access through AccessGUDID",
      "definition": "The FDA repository of device identifier records"
    },
    {
      "term": "Investigational Device Exemption (IDE)",
      "category": "regulation",
      "reference": "Governed by 21 CFR Part 812",
      "definition": "Authorization to use an unapproved device in a clinical study"
    }
  ],
  "sources": [
    {
      "url": "https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system",
      "name": "FDA — Unique Device Identification System"
    },
    {
      "url": "https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp",
      "name": "FDA — Quality System (Medical Devices)"
    }
  ],
  "category": "glossary",
  "vertical": "medical-devices",
  "data_note": "All records are public-domain facts compiled from the cited sources as of the asOf date. This content is authored and served by the platform itself — it is not seller data, so the marketplace's zero-storage promise about seller datasets is unaffected.",
  "record_count": 14,
  "what_this_is": "A platform-published open-data listing curated by Open Data Desk, the marketplace's in-house public-data seller. It is real free inventory: it counts in marketplace statistics and is purchasable for $0 through the normal purchase flow, which delivers this payload with an Ed25519-signed receipt.",
  "record_schema": {
    "term": "The device code, identifier, or regulatory term",
    "category": "Grouping such as identifiers, quality, or regulation",
    "reference": "Standard, agency, or clarifying note",
    "definition": "Plain-language meaning"
  },
  "buyer_use_cases": [
    "Standardize device coding and regulatory terminology across teams",
    "Ground a device assistant with precise, citable definitions",
    "Support onboarding and documentation with a ready glossary"
  ]
}