name: openFDA Vocabulary
description: >-
  Domain vocabulary for the openFDA public data APIs. Captures the regulatory,
  scientific, and operational terms that recur across drug, device, food,
  animal & veterinary, and tobacco datasets.
provider: openFDA
providerId: openfda
modified: '2026-05-25'
dimensions:
  - name: Product Domain
    terms:
      - id: drug
        label: Drug
        definition: Human drug products regulated by CDER, including prescription, OTC, biologic, and compounded items.
      - id: device
        label: Device
        definition: Medical devices regulated by CDRH (Class I-III), including in vitro diagnostics and combination products.
      - id: food
        label: Food
        definition: Food and dietary supplement products regulated by CFSAN.
      - id: animal-veterinary
        label: Animal & Veterinary
        definition: Animal drug and feed products regulated by CVM.
      - id: tobacco
        label: Tobacco
        definition: Tobacco products regulated by CTP.
      - id: other
        label: Other
        definition: Cross-cutting reference datasets — NSDE, substance registration, historical documents.
  - name: Regulatory Process
    terms:
      - id: adverse-event
        label: Adverse Event
        definition: A spontaneously reported event of harm associated with the use of a regulated product.
      - id: enforcement-report
        label: Enforcement Report
        definition: A weekly publication of formally classified recall actions taken by industry under FDA oversight.
      - id: recall
        label: Recall
        definition: A removal or correction of a marketed product that violates FDA-administered laws.
      - id: labeling
        label: Labeling
        definition: The Structured Product Labeling (SPL) record describing indications, dosage, warnings, and ingredients.
      - id: approval
        label: Approval
        definition: An FDA decision authorizing marketing of a new drug, biologic, or device.
      - id: 510k
        label: 510(k)
        definition: A premarket notification establishing substantial equivalence for a Class II device.
      - id: pma
        label: PMA
        definition: A Premarket Approval Application for a Class III device.
  - name: Identifier Systems
    terms:
      - id: ndc
        label: NDC
        definition: National Drug Code — a 3-segment FDA-administered identifier for drug products.
      - id: udi
        label: UDI
        definition: Unique Device Identifier — globally unique identifier for medical devices required by 21 CFR 830.
      - id: spl-id
        label: SPL Set ID
        definition: A persistent identifier for a product labeling document across its versions.
      - id: nsde
        label: NSDE
        definition: NDC SPL Data Elements — a comprehensive list of drugs marketed in the US under unique NDC codes.
  - name: Query Surface
    terms:
      - id: search
        label: search
        definition: Lucene-style query parameter used by every openFDA endpoint to filter records.
      - id: count
        label: count
        definition: Aggregation parameter that returns frequency counts for a field instead of full documents.
      - id: limit
        label: limit
        definition: Page-size parameter (max 1000) controlling how many documents an endpoint returns.
      - id: skip
        label: skip
        definition: Pagination offset parameter (max 25,000) that, combined with limit, walks result pages.
  - name: Operational
    terms:
      - id: api-key
        label: API Key
        definition: A free api.data.gov key that raises the daily quota from 1,000 to 120,000 requests per day.
      - id: rate-limit
        label: Rate Limit
        definition: 240 requests/minute per IP or per key; 1000/day anonymous, 120000/day with key.
      - id: not-clinical
        label: Not for Clinical Decisions
        definition: openFDA data is explicitly not validated for individual clinical care or public health alerting.