{
  "meta": {
    "schemaVersion": "INAV-DOSSIER-1",
    "generatedAt": "2026-07-31",
    "asOf": "2026-07-31",
    "entityId": "regulation:fr-2026-15074",
    "entityType": "regulation"
  },
  "entity": {
    "id": "regulation:fr-2026-15074",
    "type": "regulation",
    "label": "Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction",
    "url": "https://www.federalregister.gov/documents/2026/07/27/2026-15074/medical-devices-gastroenterology-urology-devices-classification-of-the-non-medicated-topical",
    "attributes": {
      "summary": "The Food and Drug Administration (FDA) is classifying the non- medicated topical formulation for treatment of erectile dysfunction into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the non-medicated topical formulation for treatment of erectile dysfunction. We are taking ",
      "agency": "Health and Human Services Department",
      "jurisdiction": "US",
      "effectiveDate": "2026-07-27",
      "daysUntilEffective": -4,
      "urgencyBand": "active",
      "urgencyRank": 0,
      "verticals": [],
      "keywords": [
        "classification",
        "devices",
        "gastroenterology",
        "medical",
        "medicated",
        "urology"
      ]
    },
    "firstSeen": "2026-07-31",
    "sources": [
      "https://www.federalregister.gov/documents/2026/07/27/2026-15074/medical-devices-gastroenterology-urology-devices-classification-of-the-non-medicated-topical",
      "data/regulatory-clock.json"
    ]
  },
  "type": "regulation",
  "href": "/entity/regulation/fr-2026-15074/",
  "headline": "Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction: a regulation cited by 5 reports across 1 vertical, first seen 2026-07-31.",
  "links": [
    {
      "edgeType": "mandated-by",
      "label": "Mandated by",
      "links": [
        {
          "id": "idea:consumer-health-and-safety-signal-monitor-crispr-tech-selectively-shreds-cancer-cells-including-undruggable-cancers",
          "label": "Consumer health and safety signal monitor: CRISPR tech selectively shreds cancer cells, including \"undruggable\" cancers",
          "type": "idea",
          "href": "/ideas/consumer-health-and-safety-signal-monitor-crispr-tech-selectively-shreds-cancer-cells-including-undruggable-cancers/",
          "linkable": true,
          "edgeType": "mandated-by",
          "direction": "in",
          "method": "classified",
          "detail": "terms food, health"
        },
        {
          "id": "idea:permit-renewal-calendar-for-mobile-food-vendors",
          "label": "Permit renewal calendar for mobile food vendors",
          "type": "idea",
          "href": "/ideas/permit-renewal-calendar-for-mobile-food-vendors/",
          "linkable": true,
          "edgeType": "mandated-by",
          "direction": "in",
          "method": "classified",
          "detail": "terms food, services"
        },
        {
          "id": "idea:pocket-voice-lab",
          "label": "Pocket voice lab",
          "type": "idea",
          "href": "/ideas/pocket-voice-lab/",
          "linkable": true,
          "edgeType": "mandated-by",
          "direction": "in",
          "method": "classified",
          "detail": "terms health, language"
        },
        {
          "id": "idea:remote-work-strength-tests",
          "label": "Remote work strength tests",
          "type": "idea",
          "href": "/ideas/remote-work-strength-tests/",
          "linkable": true,
          "edgeType": "mandated-by",
          "direction": "in",
          "method": "classified",
          "detail": "terms health, medical"
        },
        {
          "id": "idea:women-s-health-radar",
          "label": "Women's health radar",
          "type": "idea",
          "href": "/ideas/women-s-health-radar/",
          "linkable": true,
          "edgeType": "mandated-by",
          "direction": "in",
          "method": "classified",
          "detail": "terms health, treatment"
        },
        {
          "id": "vertical:healthcare",
          "label": "Healthcare & Life Sciences",
          "type": "vertical",
          "href": "/verticals/healthcare/",
          "linkable": true,
          "edgeType": "mandated-by",
          "direction": "in",
          "method": "classified",
          "detail": "health, medical"
        }
      ]
    }
  ],
  "linkCount": 6,
  "analytics": {
    "generic": {
      "ideaReach": 5,
      "verticalReach": 1,
      "citationEdges": 6,
      "firstSeen": "2026-07-31",
      "primaryVertical": "healthcare"
    }
  },
  "signals": [
    {
      "label": "Reach",
      "value": "5 reports · 1 vertical",
      "tone": "positive",
      "source": "/explore/"
    },
    {
      "label": "First seen",
      "value": "2026-07-31",
      "tone": "neutral",
      "source": "/changes/"
    },
    {
      "label": "Evidence",
      "value": "cited on 6 provenance edges",
      "tone": "neutral",
      "source": "/provenance/"
    }
  ],
  "recommendedActions": [
    {
      "id": "explore-vertical",
      "label": "Explore healthcare intelligence",
      "rationale": "This regulation evidences the healthcare vertical — open its forward cut.",
      "href": "/pro/intelligence/healthcare/"
    },
    {
      "id": "trace-graph",
      "label": "Trace in the graph explorer",
      "rationale": "Inspect every linked object and its provenance method.",
      "href": "/explore/"
    }
  ],
  "provenanceTrail": [
    {
      "claim": "Reaches 5 reports across 1 vertical in the ontology graph",
      "source": "/explore/"
    },
    {
      "claim": "First observed 2026-07-31",
      "source": "/changes/"
    }
  ],
  "asOf": "2026-07-31"
}