U.S. Food & Drug Administration (openFDA)

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Connector Details

Type

Virtual machines, Single VM , BYOL

Runs on

Google Compute Engine

Last Update

24 October, 2024

Category

Overview

The openFDA Connector facilitates seamless integration with the openFDA API, providing access to a wide range of U.S. Food and Drug Administration (FDA) datasets, including drugs, devices, food, animal and veterinary, tobacco, and other regulatory information. This connector acts as a proxy to streamline data retrieval, supporting actions for querying adverse events, drug shortages, device clearances, and more. No API key is required for accessing the openFDA API.

Integration Overview

This document provides a detailed guide for each integration point, its purpose, configuration, and workflow support using the openFDA Connector. The connector leverages the openFDA API to query FDA datasets with flexible search parameters and limits on returned results.

Supported Integration Action Points

getAnimalVeterinaryEvents: Retrieves adverse event records for animal and veterinary products.
getDrugEvents: Retrieves adverse event records for drugs.
getDrugLabels: Retrieves drug labeling information.
getDrugNdc: Retrieves National Drug Code (NDC) records.
getDrugEnforcement: Retrieves drug enforcement action records.
getDrugsFda: Retrieves records from the Drugs@FDA database.
getDrugShortages: Retrieves drug shortage records.
getDevice510k: Retrieves 510(k) premarket notification records for devices.
getDeviceClassification: Retrieves device classification records.
getDeviceEnforcement: Retrieves device enforcement action records.
getDeviceEvents: Retrieves device adverse event records.
getDevicePma: Retrieves Premarket Approval (PMA) records for devices.
getDeviceRecalls: Retrieves device recall records.
getDeviceRegistrationListing: Retrieves device registration and listing records.
getDeviceCovid19Serology: Retrieves records related to COVID-19 serology tests.
getDeviceUdi: Retrieves Unique Device Identification (UDI) records.
getFoodEnforcement: Retrieves food enforcement action records.
getFoodEvents: Retrieves food adverse event records.
getHistoricalDocuments: Retrieves historical document records.
getNsde: Retrieves National Surveillance Data Elements (NSDE) records.
getSubstance: Retrieves substance data records.
getUnii: Retrieves Unique Ingredient Identifier (UNII) records.
getTobaccoProblems: Retrieves tobacco problem report records.

Detailed Integration Documentation

Animal and Veterinary Adverse Events Retrieval

Action	getAnimalVeterinaryEvents
Purpose	Retrieves adverse event records for animal and veterinary products, enabling analysis of safety issues related to veterinary drugs and products.
Parameters	Optional: search: Search query in the format field:term, e.g., original_receive_date:[20040101+TO+20161107] or animal.species:dog. Supports AND/OR operators, phrase matches, and date ranges (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the base URL via the CONNECTOR_ENV_OPENFDA_BASE_URL environment variable.
Output	Successful: Returns a JSON object with: results: Array of adverse event records (array of objects, structure varies by dataset). meta: Metadata including query details and result count (object). Failure: Returns error details (e.g., {"error": "No matches found!"} for invalid search fields, HTTP 404).
Workflow Example	Configure the connector with the base URL. Execute the getAnimalVeterinaryEvents action with search=original_receive_date:[20040101+TO+20161107]&limit=5. Process the response to analyze veterinary adverse events for reporting or research.

Drug Adverse Events Retrieval

Action	getDrugEvents
Purpose	Retrieves adverse event records for drugs, supporting pharmacovigilance and safety monitoring.
Parameters	Optional: search: Search query, e.g., receivedate:[20040101+TO+20081231] or patient.drug.medicinalproduct:aspirin (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of adverse event records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 400 for invalid syntax, HTTP 404 for invalid fields).
Workflow Example	Execute the getDrugEvents action with search=receivedate:[20040101+TO+20081231]&limit=5. Review the response to identify drug safety trends. Use the data for regulatory reporting or analysis.

Drug Labeling Information Retrieval

Action	getDrugLabels
Purpose	Retrieves drug labeling information, useful for regulatory compliance and product information analysis.
Parameters	Optional: search: Search query, e.g., effective_time:[20110601+TO+20121231] or brand_name:Advil (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of drug labeling records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getDrugLabels action with search=effective_time:[20110601+TO+20121231]&limit=5. Process the response to extract labeling information. Use the data for compliance checks or product documentation.

National Drug Code (NDC) Retrieval

Action	getDrugNdc
Purpose	Retrieves National Drug Code (NDC) records, supporting drug identification and inventory management.
Parameters	Optional: search: Search query, e.g., finished:true or generic_name:ibuprofen (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of NDC records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getDrugNdc action with search=finished:true&limit=5. Review the response to identify drug codes. Use the data for inventory tracking or regulatory reporting.

Drug Enforcement Actions Retrieval

Action	getDrugEnforcement
Purpose	Retrieves drug enforcement action records, enabling monitoring of regulatory actions.
Parameters	Optional: search: Search query, e.g., report_date:[20040101+TO+20131231] or product_description:contaminated (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of enforcement action records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getDrugEnforcement action with search=report_date:[20040101+TO+20131231]&limit=5. Analyze the response for enforcement trends. Use the data for compliance monitoring.

Drugs@FDA Database Retrieval

Action	getDrugsFda
Purpose	Retrieves records from the Drugs@FDA database, supporting drug approval and regulatory analysis.
Parameters	Optional: search: Search query, e.g., brand_name:Tylenol or application_number:ANDA123456 (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of Drugs@FDA records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getDrugsFda action with search=brand_name:Tylenol&limit=5. Review the response for drug approval details. Use the data for regulatory submissions or market analysis.

Drug Shortages Retrieval

Action	getDrugShortages
Purpose	Retrieves drug shortage records, enabling tracking of supply chain issues for medications.
Parameters	Optional: search: Search query, e.g., generic_name:aspirin or shortage_status:Current (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of drug shortage records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields like advisory_committee).
Workflow Example	Execute the getDrugShortages action with search=shortage_status:Current&limit=5. Save the response for supply chain monitoring. Use the data to inform healthcare providers or patients.

Device 510(k) Clearances Retrieval

Action	getDevice510k
Purpose	Retrieves 510(k) premarket notification records for medical devices, supporting regulatory compliance and market analysis.
Parameters	Optional: search: Search query, e.g., advisory_committee:cv or device_name:catheter (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of 510(k) records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getDevice510k action with search=advisory_committee:cv&limit=5. Review the response to identify cleared devices. Use the data for regulatory submissions or competitive analysis.

Device Classifications Retrieval

Action	getDeviceClassification
Purpose	Retrieves device classification records, supporting regulatory and product development processes.
Parameters	Optional: search: Search query, e.g., regulation_number:872.6855 or device_name:dental (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of classification records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getDeviceClassification action with search=regulation_number:872.6855&limit=5. Process the response to understand device classifications. Use the data for product development or compliance.

Device Enforcement Actions Retrieval

Action	getDeviceEnforcement
Purpose	Retrieves device enforcement action records, enabling monitoring of regulatory actions.
Parameters	Optional: search: Search query, e.g., report_date:[20040101+TO+20131231] or product_description:defective (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of enforcement action records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getDeviceEnforcement action with search=report_date:[20040101+TO+20131231]&limit=5. Analyze the response for enforcement trends. Use the data for compliance monitoring.

Device Adverse Events Retrieval

Action	getDeviceEvents
Purpose	Retrieves adverse event records for medical devices, enabling safety monitoring and risk assessment.
Parameters	Optional: search: Search query, e.g., date_received:[20130101+TO+20141231] or device.device_report_product_code:FOZ (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of adverse event records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getDeviceEvents action with search=date_received:[20130101+TO+20141231]&limit=5. Analyze the response for device safety issues. Use the data for post-market surveillance.

Premarket Approval (PMA) Records Retrieval

Action	getDevicePma
Purpose	Retrieves Premarket Approval (PMA) records for medical devices, supporting regulatory analysis.
Parameters	Optional: search: Search query, e.g., decision_code:APPR or generic_name:pacemaker (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of PMA records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getDevicePma action with search=decision_code:APPR&limit=5. Review the response for approved devices. Use the data for regulatory submissions.

Device Recalls Retrieval

Action	getDeviceRecalls
Purpose	Retrieves device recall records, supporting safety and compliance monitoring.
Parameters	Optional: search: Search query, e.g., product_code:FOZ or recall_status:Open (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of recall records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getDeviceRecalls action with search=product_code:FOZ&limit=5. Process the response to identify recalled devices. Use the data for safety alerts or compliance.

Device Registration and Listing Retrieval

Action	getDeviceRegistrationListing
Purpose	Retrieves device registration and listing records, supporting regulatory compliance and market analysis.
Parameters	Optional: search: Search query, e.g., products.product_code:HQY or establishment_type:manufacturer (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of registration and listing records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getDeviceRegistrationListing action with search=products.product_code:HQY&limit=5. Review the response for registered devices. Use the data for market analysis or compliance.

COVID-19 Serology Tests Retrieval

Action	getDeviceCovid19Serology
Purpose	Retrieves records related to COVID-19 serology tests, supporting pandemic response and research.
Parameters	Optional: search: Search query, e.g., test_name:antibody or manufacturer:covid (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of COVID-19 serology test records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getDeviceCovid19Serology action with limit=5. Process the response to analyze serology tests. Use the data for public health research.

Unique Device Identification (UDI) Retrieval

Action	getDeviceUdi
Purpose	Retrieves Unique Device Identification (UDI) records, supporting device tracking and regulatory compliance.
Parameters	Optional: search: Search query, e.g., _exists_:public_device_record_key or di:123456789 (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of UDI records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getDeviceUdi action with search=_exists_:public_device_record_key&limit=5. Review the response for device identifiers. Use the data for supply chain tracking.

Food Enforcement Actions Retrieval

Action	getFoodEnforcement
Purpose	Retrieves food enforcement action records, enabling monitoring of food safety regulations.
Parameters	Optional: search: Search query, e.g., report_date:[20040101+TO+20131231] or product_type:vegetable (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of enforcement action records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getFoodEnforcement action with search=report_date:[20040101+TO+20131231]&limit=5. Analyze the response for food safety violations. Use the data for regulatory compliance.

Food Adverse Events Retrieval

Action	getFoodEvents
Purpose	Retrieves adverse event records related to food products, supporting food safety monitoring.
Parameters	Optional: search: Search query, e.g., date_started:[20040101+TO+20160101] or product_description:salmonella (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of adverse event records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getFoodEvents action with search=date_started:[20040101+TO+20160101]&limit=5. Process the response to identify food safety incidents. Use the data for public health alerts.

Historical Documents Retrieval

Action	getHistoricalDocuments
Purpose	Retrieves historical document records, supporting research and regulatory analysis.
Parameters	Optional: search: Search query, e.g., doc_type:pr+AND+year:1919+AND+text:Botulism (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of historical document records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getHistoricalDocuments action with search=doc_type:pr+AND+year:1919&limit=5. Review the response for historical insights. Use the data for academic research.

National Surveillance Data Elements (NSDE) Retrieval

Action	getNsde
Purpose	Retrieves National Surveillance Data Elements (NSDE) records, supporting regulatory data analysis.
Parameters	Optional: search: Search query, e.g., dataset-specific fields (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of NSDE records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getNsde action with limit=5. Process the response to analyze surveillance data. Use the data for regulatory reporting.

Substance Data Retrieval

Action	getSubstance
Purpose	Retrieves substance data records, supporting chemical and regulatory analysis.
Parameters	Optional: search: Search query, e.g., dataset-specific fields like substance_name:aspirin (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of substance data records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getSubstance action with limit=5. Review the response for substance details. Use the data for chemical analysis or compliance.

Unique Ingredient Identifier (UNII) Retrieval

Action	getUnii
Purpose	Retrieves Unique Ingredient Identifier (UNII) records, supporting ingredient tracking and regulatory compliance.
Parameters	Optional: search: Search query, e.g., dataset-specific fields like unii:362O9ITL9D (string). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of UNII records (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getUnii action with limit=5. Process the response to identify ingredient identifiers. Use the data for regulatory compliance.

Tobacco Problem Reports Retrieval

Action	getTobaccoProblems
Purpose	Retrieves problem reports for tobacco products, supporting regulatory oversight and consumer safety.
Parameters	Optional: search: Search query, e.g., filter by product type or issue (string, dataset-specific fields). limit: Number of records to return (integer, 1-1000, default: 1).
Configuration	Ensure the connector is configured with the correct base URL.
Output	Successful: Returns a JSON object with: results: Array of problem reports (array of objects). meta: Metadata including query details (object). Failure: Returns error details (e.g., HTTP 404 for invalid fields).
Workflow Example	Execute the getTobaccoProblems action with limit=5. Review the response for tobacco-related issues. Use the data for regulatory reporting or consumer education.

Workflow Creation with the Connector

Example Workflow: Drug Safety and Device Compliance Analysis

Query Drug Adverse Events	Use the `getDrugEvents` action with `search=receivedate:[20230601+TO+20250601]&limit=10` to fetch recent drug adverse events. Process the response to identify safety trends for a specific drug (e.g., `patient.drug.medicinalproduct:aspirin`).
Monitor Drug Shortages	Execute the `getDrugShortages` action with `search=shortage_status:Current&limit=5` to retrieve current drug shortages. Save the results for supply chain management or patient notifications.
Analyze Device 510(k) Clearances	Use the `getDevice510k` action with `search=advisory_committee:cv&limit=5` to fetch cardiovascular device clearances. Review the response for market analysis or regulatory submissions.
Track Device Adverse Events	Execute the `getDeviceEvents` action with `search=date_received:[20230101+TO+20251231]&limit=10` to retrieve recent device adverse events. Analyze the data for post-market surveillance or risk assessment.
Enhance Reporting with Food Safety Data	Use the `getFoodEvents` action with `search=date_started:[20240101+TO+20250601]&limit=5` to fetch food adverse events. Integrate the data into public health reports or safety alerts.

Configuration Notes

Base URL	Set the `CONNECTOR_ENV_OPENFDA_BASE_URL` environment variable to `https://api.fda.gov`.
Error Handling	Handle HTTP 400 (invalid syntax) and 404 (invalid fields or no matches) errors gracefully. Check the response body for error details (e.g., `{"error": "No matches found!"}`).
Search Fields	Valid fields for the `search` parameter vary by endpoint. Consult the openFDA documentation (e.g., https://open.fda.gov/apis/) for dataset-specific fields. Example fields include: `/drug/shortages.json`: generic_name, brand_name, shortage_status, report_date `/device/510k.json`: advisory_committee, device_name, decision_date `/animalandveterinary/event.json`: original_receive_date, animal.species
Rate Limits	The openFDA API may impose rate limits for high-volume usage. Monitor response headers for rate limit information and implement retry logic if needed.

Additional Resources

openFDA Documentation: https://open.fda.gov/apis/
Field Schemas: Refer to endpoint-specific documentation (e.g., https://open.fda.gov/apis/drug/shortages/) for valid search fields.
GCP Connector Setup: Follow GCP documentation for deploying custom connectors with the specified environment variables.

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