ORCA: Open Regulatory Change Annotation

{
  "document_number": "FDA-GD-20260310-01",
  "title": "FDA Issues Final Rule on Laboratory Developed Tests",
  "citation": null,
  "source_url": "https://www.fda.gov/regulatory-information/final-rule-ldt",
  "docket_ids": ["FDA-2023-N-2177"],
  "cfr_references": [
    {"title": 21, "part": 809},
    {"title": 21, "part": 820}
  ],

  "authority": {
    "id": "fda",
    "name": "Food and Drug Administration",
    "short_name": "FDA",
    "country": "US",
    "level": "federal",
    "parent_id": "hhs"
  },

  "jurisdiction": {
    "country": "US",
    "level": "federal",
    "subdivision": null
  },

  "dates": {
    "publication_date": "2026-03-10",
    "effective_on": "2026-04-10",
    "comment_close_date": null,
    "compliance_deadline": "2027-03-10",
    "detected_at": "2026-03-10T14:23:00Z"
  },

  "classification": {
    "type": "Rule",
    "action": "Final rule.",
    "change_type": "Added",
    "status": "Final",
    "change_scope": "Structural",
    "topics": ["Laboratory Testing", "FDA Oversight", "Clinical Diagnostics"],
    "sector": ["3345 - Medical Device Manufacturing", "6221 - Hospitals & Health Systems"],
    "related_framework": ["FDA 21 CFR Part 11", "GxP"]
  },

  "intelligence": {
    "attention_level": "Urgent",
    "legal_weight": "Binding",
    "summary": "The FDA published a final rule establishing oversight of laboratory developed tests under the FD&C Act.",
    "analysis": "The FDA has finalized its rule to regulate LDTs as medical devices...",
    "analyst_note": "Clinical labs that have historically operated under CMS/CLIA oversight only must now build an FDA-style quality system. The 12-month registration window is the binding constraint, not the 18-month adverse event reporting deadline.",
    "pull_quote": "Laboratories must register and list each laboratory developed test with the FDA within 12 months of the effective date of this rule.",
    "applies_to": ["Healthcare providers", "Medical device makers", "Clinical investigators"],
    "required_actions": [
      "Inventory all laboratory developed tests and classify by risk level",
      "Register and list LDTs with FDA within 12 months",
      "Implement adverse event reporting within 18 months"
    ],
    "penalty_info": "Warning letters, injunctions, civil penalties for non-compliance",
    "geographic_scope": "US",
    "operational_domain": "Clinical Operations",
    "related_changes": ["FDA-GD-20240501-12", "FDA-GD-20240618-03"]
  },

  "process": {
    "within_comment_period": false,
    "open_for_comment": false,
    "comment_count": null,
    "attachments": []
  },

  "metadata": {
    "enriched_at": "2026-03-10T14:25:00Z",
    "content_hash": "sha256:abc123...",
    "version": "1.3",
    "provider": "govping"
  }
}

---
document_number: FDA-GD-20260310-01
title: FDA Issues Final Rule on Laboratory Developed Tests
authority: FDA
type: Rule
status: Final
attention_level: Urgent
legal_weight: Binding
effective_on: 2026-04-10
compliance_deadline: 2027-03-10
geographic_scope: US
sector: [3345 - Medical Device Manufacturing, 6221 - Hospitals & Health Systems]
related_framework: [FDA 21 CFR Part 11, GxP]
applies_to: [Healthcare providers, Medical device makers, Clinical investigators]
source_url: https://www.fda.gov/regulatory-information/final-rule-ldt
---

The FDA published a final rule establishing oversight of laboratory
developed tests under the FD&C Act. Clinical laboratories must begin
phaseout compliance within 12 months.

## Required Actions
- Inventory all laboratory developed tests and classify by risk level
- Register and list LDTs with FDA within 12 months
- Implement adverse event reporting within 18 months

## Penalties
Warning letters, injunctions, civil penalties for non-compliance.

<entry>
  <title>FDA Issues Final Rule on Laboratory Developed Tests</title>
  <link href="https://changeflow.com/govping/changes/FDA-GD-20260310-01"/>
  <id>urn:govping:FDA-GD-20260310-01</id>
  <published>2026-03-10T14:23:00Z</published>
  <category term="Rule"/>
  <category term="Urgent"/>
  <category term="FDA"/>
  <summary>The FDA published a final rule establishing oversight of
  laboratory developed tests under the FD&C Act.</summary>
</entry>