{
  "_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": [
    {
      "item": "Class I device",
      "source": "FDA CDRH",
      "category": "risk class",
      "definition": "Lowest-risk devices subject to general controls",
      "statutory_reference": "Most are exempt from premarket notification"
    },
    {
      "item": "Class II device",
      "source": "FDA CDRH",
      "category": "risk class",
      "definition": "Moderate-risk devices requiring special controls",
      "statutory_reference": "Usually cleared through 510(k)"
    },
    {
      "item": "Class III device",
      "source": "FDA CDRH",
      "category": "risk class",
      "definition": "Highest-risk devices supporting or sustaining life",
      "statutory_reference": "Generally require premarket approval"
    },
    {
      "item": "510(k) premarket notification",
      "source": "FDA CDRH",
      "category": "pathway",
      "definition": "Submission showing a device is substantially equivalent to a legally marketed predicate",
      "statutory_reference": "Section 510(k) of the FD&C Act"
    },
    {
      "item": "Premarket approval (PMA)",
      "source": "FDA CDRH",
      "category": "pathway",
      "definition": "The most stringent device review, based on valid scientific evidence of safety and effectiveness",
      "statutory_reference": "Required for most Class III devices"
    },
    {
      "item": "De Novo classification",
      "source": "FDA CDRH",
      "category": "pathway",
      "definition": "Route for novel low-to-moderate-risk devices with no predicate",
      "statutory_reference": "Established under Section 513(f)(2)"
    },
    {
      "item": "Humanitarian Device Exemption (HDE)",
      "source": "FDA CDRH",
      "category": "pathway",
      "definition": "Pathway for devices treating conditions affecting small patient populations",
      "statutory_reference": "For conditions affecting fewer than 8,000 individuals per year in the U.S."
    },
    {
      "item": "Investigational Device Exemption (IDE)",
      "source": "FDA CDRH",
      "category": "pathway",
      "definition": "Allows an unapproved device to be used in a clinical study to collect safety and effectiveness data",
      "statutory_reference": "21 CFR Part 812"
    },
    {
      "item": "Recall Class I",
      "source": "FDA CDRH",
      "category": "recall class",
      "definition": "Reasonable probability of serious harm or death",
      "statutory_reference": "FDA recall classification"
    },
    {
      "item": "Recall Class II",
      "source": "FDA CDRH",
      "category": "recall class",
      "definition": "Temporary or medically reversible harm is possible",
      "statutory_reference": "FDA recall classification"
    },
    {
      "item": "Recall Class III",
      "source": "FDA CDRH",
      "category": "recall class",
      "definition": "Unlikely to cause harm but violates FDA rules",
      "statutory_reference": "FDA recall classification"
    },
    {
      "item": "Medical Device Reporting (MDR)",
      "source": "FDA CDRH",
      "category": "safety",
      "definition": "Mandatory reporting of device-related deaths, serious injuries, and malfunctions",
      "statutory_reference": "21 CFR Part 803"
    },
    {
      "item": "Unique Device Identification (UDI)",
      "source": "FDA CDRH",
      "category": "identifier",
      "definition": "System requiring devices to carry a unique identifier on labels and packages",
      "statutory_reference": "FDA UDI Rule"
    }
  ],
  "sources": [
    {
      "url": "https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device",
      "name": "FDA — How to Determine if Your Product is a Medical Device"
    },
    {
      "url": "https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls",
      "name": "FDA — Medical Device Recalls"
    }
  ],
  "category": "benchmarks",
  "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": 13,
  "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": {
    "item": "Class, pathway, or recall class",
    "source": "Publishing authority",
    "category": "Type of fact",
    "definition": "What it means",
    "statutory_reference": "The statute, rule, or reference basis"
  },
  "buyer_use_cases": [
    "Ground device regulatory strategy in exact class and pathway definitions",
    "Explain clearance versus approval and recall classes to stakeholders",
    "Give quality and market-access teams a citable CDRH fact base"
  ]
}