{
  "columns": [
    "element",
    "section",
    "section_record_id",
    "source_url",
    "text"
  ],
  "rows": [
    {
      "element": "p",
      "section": "Device Enforcement Overview",
      "section_record_id": 1,
      "source_url": "https://open.fda.gov/apis/device/enforcement/",
      "text": "The openFDA device enforcement reports API returns data from the FDA Recall Enterprise System (RES), a database that contains information on recall event information submitted to FDA. Currently, this data covers publicly releasable records from 2004-present. The data is updated weekly."
    },
    {
      "element": "p",
      "section": "Device Enforcement Overview",
      "section_record_id": 2,
      "source_url": "https://open.fda.gov/apis/device/enforcement/",
      "text": "The procedures followed to input recall information into RES when FDA learns of a recall event are outlined in Chapter 7 of FDA’s Regulatory Procedure Manual. The Regulatory Procedures Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters."
    },
    {
      "element": "li",
      "section": "Key Facts",
      "section_record_id": 3,
      "source_url": "https://open.fda.gov/apis/device/enforcement/",
      "text": "Source of the data:FDA Recall Enterprise System (RES)"
    },
    {
      "element": "li",
      "section": "Key Facts",
      "section_record_id": 4,
      "source_url": "https://open.fda.gov/apis/device/enforcement/",
      "text": "Changes to the source data:openFDA annotates the original records with special fields and converts the data into JSON, which is a widely used machine readable format."
    },
    {
      "element": "li",
      "section": "Key Facts",
      "section_record_id": 5,
      "source_url": "https://open.fda.gov/apis/device/enforcement/",
      "text": "Time period covered in this API:2004 to null"
    },
    {
      "element": "h3",
      "section": "Additional Information About Medical Device Recall Enforcement Reports",
      "section_record_id": 6,
      "source_url": "https://open.fda.gov/apis/device/enforcement/",
      "text": "Additional Information About Medical Device Recall Enforcement Reports"
    },
    {
      "element": "p",
      "section": "Additional Information About Medical Device Recall Enforcement Reports",
      "section_record_id": 7,
      "source_url": "https://open.fda.gov/apis/device/enforcement/",
      "text": "Recalls are an appropriate alternative method for removing or correcting marketed consumer products, their labeling, and/or promotional literature that violate the laws administered by the Food and Drug Administration (FDA). Recalls afford equal consumer protection but generally are more efficient and timely than formal administrative or civil actions, especially when the product has been widely distributed."
    },
    {
      "element": "p",
      "section": "Additional Information About Medical Device Recall Enforcement Reports",
      "section_record_id": 8,
      "source_url": "https://open.fda.gov/apis/device/enforcement/",
      "text": "Manufacturers and/or distributors may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA."
    }
  ]
}