483 Regulatory Mapping

Browse cross-reference mappings between 21 CFR sections cited in FDA 483 observations and ICH E6(R3) Good Clinical Practice requirements. Understand how inspection findings relate to international regulatory standards.

GET /v1/483/regulatory-mapping

List all CFR-to-ICH E6(R3) regulatory mappings, with optional filtering by relevance score, mapping availability, and requirement keyword.

Request

GET https://api.ctwise.ai/v1/483/regulatory-mapping?has_mappings=true&min_relevance=0.7&limit=20
X-Api-Key: YOUR_API_KEY

Query Parameters

Parameter	Type	Required	Description
has_mappings	boolean	No	When true, only return CFR sections that have ICH E6(R3) mappings (default: false)
min_relevance	number	No	Minimum relevance score for ICH mappings (0.0-1.0, default: 0.0)
requirement	string	No	Filter by ICH requirement keyword (e.g., "informed consent")
offset	integer	No	Pagination offset (default: 0)
limit	integer	No	Results per page (default: 50, max: 100)

Response

{
  "mappings": [
    {
      "cfr_section": "21 CFR 211.68",
      "cfr_title": "Automatic, mechanical, and electronic equipment calibration",
      "occurrence_count": 1247,
      "ich_mappings": [
        {
          "ich_section": "E6(R3) 6.5.3",
          "matched_requirement": "Computerized systems used in clinical trials should be validated for their intended use",
          "relevance_score": 0.82,
          "mapping_rationale": "Equipment calibration requirements parallel ICH E6(R3) computerized system validation"
        },
        {
          "ich_section": "E6(R3) 5.18.4",
          "matched_requirement": "The sponsor should ensure that clinical sites have adequate equipment",
          "relevance_score": 0.71,
          "mapping_rationale": "Site equipment adequacy linked to calibration compliance"
        }
      ],
      "source": "FDA Inspection Database + ICH Guidelines Config",
      "source_url": "https://datadashboard.fda.gov/ora/cd/inspections.htm",
      "data_attribution": {
        "retrieved_at": "2026-02-23T14:30:00Z",
        "api_version": "v1",
        "data_source_name": "FDA CDER ORA Inspections + ICH E6(R3)",
        "data_source_url": "https://datadashboard.fda.gov/ora/cd/inspections.htm"
      }
    }
  ],
  "total": 156,
  "offset": 0,
  "limit": 20,
  "filters_applied": {
    "has_mappings": true,
    "min_relevance": 0.7,
    "requirement": null
  },
  "query_metadata": {
    "execution_time_ms": 85
  },
  "source": "FDA Inspection Database + ICH Guidelines Config",
  "source_url": "https://datadashboard.fda.gov/ora/cd/inspections.htm",
  "data_attribution": {
    "retrieved_at": "2026-02-23T14:30:00Z",
    "api_version": "v1",
    "data_source_name": "FDA CDER ORA Inspections + ICH E6(R3)",
    "data_source_url": "https://datadashboard.fda.gov/ora/cd/inspections.htm"
  }
}

Response Fields

Field	Type	Description
mappings	array	Array of CFR-to-ICH mapping entries
mappings[].cfr_section	string	21 CFR section number (e.g., "21 CFR 211.68")
mappings[].cfr_title	string	Short description of the CFR section
mappings[].occurrence_count	integer	Number of times this CFR is cited in 483 observations
mappings[].ich_mappings	array	ICH E6(R3) requirements mapped to this CFR
mappings[].ich_mappings[].ich_section	string	ICH E6(R3) section reference
mappings[].ich_mappings[].matched_requirement	string	Relevant ICH requirement text
mappings[].ich_mappings[].relevance_score	number	Relevance score (0.0-1.0)
mappings[].ich_mappings[].mapping_rationale	string	Explanation of why this mapping applies
total	integer	Total matching entries
offset	integer	Current pagination offset
limit	integer	Results per page
filters_applied	object	Applied filter parameters
query_metadata	object	Query execution metadata

---

GET /v1/483/regulatory-mapping/{cfr}

Get ICH E6(R3) mapping detail for a specific CFR section.

Request

GET https://api.ctwise.ai/v1/483/regulatory-mapping/21%20CFR%20211.68
X-Api-Key: YOUR_API_KEY

Path Parameters

Parameter	Type	Required	Description
cfr	string	Yes	CFR section number (URL-encoded, e.g., 21%20CFR%20211.68)

Response

{
  "cfr_section": "21 CFR 211.68",
  "cfr_title": "Automatic, mechanical, and electronic equipment calibration",
  "occurrence_count": 1247,
  "ich_mappings": [
    {
      "ich_section": "E6(R3) 6.5.3",
      "matched_requirement": "Computerized systems used in clinical trials should be validated for their intended use",
      "relevance_score": 0.82,
      "mapping_rationale": "Equipment calibration requirements parallel ICH E6(R3) computerized system validation"
    },
    {
      "ich_section": "E6(R3) 5.18.4",
      "matched_requirement": "The sponsor should ensure that clinical sites have adequate equipment",
      "relevance_score": 0.71,
      "mapping_rationale": "Site equipment adequacy linked to calibration compliance"
    }
  ],
  "source": "FDA Inspection Database + ICH Guidelines Config",
  "source_url": "https://datadashboard.fda.gov/ora/cd/inspections.htm",
  "cfr_reference_url": "https://www.ecfr.gov/current/title-21/chapter-I/part-211",
  "data_attribution": {
    "retrieved_at": "2026-02-23T14:30:00Z",
    "api_version": "v1",
    "data_source_name": "FDA CDER ORA Inspections + ICH E6(R3)",
    "data_source_url": "https://datadashboard.fda.gov/ora/cd/inspections.htm"
  },
  "query_metadata": {
    "execution_time_ms": 42
  }
}

Response Fields

Field	Type	Description
cfr_section	string	21 CFR section number
cfr_title	string	Short description of the CFR section
occurrence_count	integer	Number of 483 citations for this CFR
ich_mappings	array	ICH E6(R3) requirements mapped to this CFR
cfr_reference_url	string	Link to eCFR source for this regulation
data_attribution	object	Data source attribution
query_metadata	object	Query execution metadata

---

Examples

List All CFR Sections with ICH Mappings

curl "https://api.ctwise.ai/v1/483/regulatory-mapping?has_mappings=true&limit=10" \
  -H "X-Api-Key: YOUR_API_KEY"

Filter by Minimum Relevance Score

curl "https://api.ctwise.ai/v1/483/regulatory-mapping?has_mappings=true&min_relevance=0.8&limit=20" \
  -H "X-Api-Key: YOUR_API_KEY"

Search by ICH Requirement Keyword

curl "https://api.ctwise.ai/v1/483/regulatory-mapping?requirement=informed+consent&has_mappings=true" \
  -H "X-Api-Key: YOUR_API_KEY"

Get Detail for a Specific CFR Section

curl "https://api.ctwise.ai/v1/483/regulatory-mapping/21%20CFR%20211.68" \
  -H "X-Api-Key: YOUR_API_KEY"

Python Example

import requests

API_KEY = "your_api_key"
BASE_URL = "https://api.ctwise.ai/v1"

# List CFR sections with high-relevance ICH mappings
response = requests.get(
    f"{BASE_URL}/483/regulatory-mapping",
    headers={"X-Api-Key": API_KEY},
    params={
        "has_mappings": "true",
        "min_relevance": 0.7,
        "limit": 20
    }
)

data = response.json()
print(f"Total CFR sections with ICH mappings: {data['total']}\n")

for mapping in data["mappings"]:
    print(f"{mapping['cfr_section']}: {mapping['cfr_title']}")
    print(f"  483 Citations: {mapping['occurrence_count']}")
    for ich in mapping["ich_mappings"]:
        print(f"  -> {ich['ich_section']} (relevance: {ich['relevance_score']:.2f})")
        print(f"     {ich['matched_requirement'][:80]}...")
    print()

# Get detail for a specific CFR section
detail = requests.get(
    f"{BASE_URL}/483/regulatory-mapping/21 CFR 211.68",
    headers={"X-Api-Key": API_KEY}
).json()

print(f"\nDetail: {detail['cfr_section']}")
print(f"eCFR Link: {detail['cfr_reference_url']}")
for ich in detail["ich_mappings"]:
    print(f"  {ich['ich_section']}: {ich['matched_requirement']}")
    print(f"  Rationale: {ich['mapping_rationale']}")

JavaScript Example

const API_KEY = 'your_api_key';
const BASE_URL = 'https://api.ctwise.ai/v1';

// List CFR sections mapped to ICH E6(R3)
const response = await fetch(
  `${BASE_URL}/483/regulatory-mapping?has_mappings=true&min_relevance=0.7&limit=20`,
  { headers: { 'X-Api-Key': API_KEY } }
);

const data = await response.json();
console.log(`Total mapped CFR sections: ${data.total}`);

data.mappings.forEach(mapping => {
  console.log(`${mapping.cfr_section} (${mapping.occurrence_count} citations)`);
  mapping.ich_mappings.forEach(ich => {
    console.log(`  -> ${ich.ich_section}: ${ich.matched_requirement}`);
    console.log(`     Relevance: ${ich.relevance_score}`);
  });
});

// Get detail for specific CFR
const detail = await fetch(
  `${BASE_URL}/483/regulatory-mapping/${encodeURIComponent('21 CFR 211.68')}`,
  { headers: { 'X-Api-Key': API_KEY } }
).then(r => r.json());

console.log(`\neCFR Link: ${detail.cfr_reference_url}`);

Error Responses

CFR Section Not Found

{
  "error": "CFR reference not found: 21 CFR 999.99",
  "status_code": 404
}

Status: 404 Not Found

Invalid API Key

{
  "message": "Unauthorized"
}

Status: 401 Unauthorized

Rate Limit Exceeded

{
  "error": {
    "code": "RATE_LIMIT_EXCEEDED",
    "message": "Rate limit exceeded. Please try again later.",
    "retry_after": 60
  }
}

Status: 429 Too Many Requests

Performance

Metric	Target
List response time	< 500ms
Detail response time	< 200ms
Max results per page	100
Cache TTL	5 minutes

---

Related Endpoints

• GET /v1/483/cfr-references - Browse CFR citation statistics
• POST /v1/483/observations/search - Semantic search across 483 observations
• GET /v1/483/analytics/summary - Aggregate 483 statistics