Custom Connector
U.S. Food & Drug Administration (openFDA)
Global
The openFDA Connector facilitates seamless integration with the openFDA API, providing access to a wide range of U.S. FDA datasets — drugs, devices, food, animal and veterinary, tobacco, and other regulatory information. It acts as a proxy for querying adverse events, drug shortages, device clearances, and more. No API key is required.
Overview
Integration Overview
This document provides a detailed guide for each integration point, its purpose, configuration, and workflow support using the openFDA Connector, querying FDA datasets with flexible search parameters and result limits.
- getAnimalVeterinaryEvents. Adverse event records for animal and veterinary products.
- getDrugEvents. Adverse event records for drugs.
- getDrugLabels. Drug labeling information.
- getDrugNdc. National Drug Code (NDC) records.
- getDrugEnforcement. Drug enforcement action records.
- getDrugsFda. Records from the Drugs@FDA database.
- getDrugShortages. Drug shortage records.
- getDevice510k. 510(k) premarket notification records.
- getDeviceClassification. Device classification records.
- getDeviceEnforcement. Device enforcement action records.
- getDeviceEvents. Device adverse event records.
- getDevicePma. Premarket Approval (PMA) records.
- getDeviceRecalls. Device recall records.
- getDeviceRegistrationListing. Device registration and listing records.
- getDeviceCovid19Serology. COVID-19 serology test records.
- getDeviceUdi. Unique Device Identification (UDI) records.
- getFoodEnforcement. Food enforcement action records.
- getFoodEvents. Food adverse event records.
- getHistoricalDocuments. Historical document records.
- getNsde. National Surveillance Data Elements records.
- getSubstance. Substance data records.
- getUnii. Unique Ingredient Identifier records.
- getTobaccoProblems. Tobacco problem report records.
Documentation
Detailed Integration Documentation
Animal & Veterinary Adverse Events
| Action | getAnimalVeterinaryEvents |
|---|---|
| Purpose | Retrieves adverse event records for animal and veterinary products. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getAnimalVeterinaryEvents with search=animal.species:dog&limit=5, then process the results for reporting, research, or compliance. |
Drug Adverse Events
| Action | getDrugEvents |
|---|---|
| Purpose | Retrieves adverse event records for drugs, supporting pharmacovigilance and safety monitoring. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getDrugEvents with search=patient.drug.medicinalproduct:aspirin&limit=5, then process the results for reporting, research, or compliance. |
Drug Labeling Information
| Action | getDrugLabels |
|---|---|
| Purpose | Retrieves drug labeling information for regulatory compliance and product analysis. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getDrugLabels with search=brand_name:Advil&limit=5, then process the results for reporting, research, or compliance. |
National Drug Code (NDC)
| Action | getDrugNdc |
|---|---|
| Purpose | Retrieves National Drug Code (NDC) records for drug identification and inventory. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getDrugNdc with search=generic_name:ibuprofen&limit=5, then process the results for reporting, research, or compliance. |
Drug Enforcement Actions
| Action | getDrugEnforcement |
|---|---|
| Purpose | Retrieves drug enforcement action records for monitoring regulatory actions. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getDrugEnforcement with search=report_date:[20040101+TO+20131231]&limit=5, then process the results for reporting, research, or compliance. |
Drugs@FDA Database
| Action | getDrugsFda |
|---|---|
| Purpose | Retrieves records from the Drugs@FDA database for approval and regulatory analysis. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getDrugsFda with search=brand_name:Tylenol&limit=5, then process the results for reporting, research, or compliance. |
Drug Shortages
| Action | getDrugShortages |
|---|---|
| Purpose | Retrieves drug shortage records for tracking supply chain issues. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getDrugShortages with search=shortage_status:Current&limit=5, then process the results for reporting, research, or compliance. |
Device 510(k) Clearances
| Action | getDevice510k |
|---|---|
| Purpose | Retrieves 510(k) premarket notification records for medical devices. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getDevice510k with search=advisory_committee:cv&limit=5, then process the results for reporting, research, or compliance. |
Device Classifications
| Action | getDeviceClassification |
|---|---|
| Purpose | Retrieves device classification records for regulatory and product development. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getDeviceClassification with search=regulation_number:872.6855&limit=5, then process the results for reporting, research, or compliance. |
Device Enforcement Actions
| Action | getDeviceEnforcement |
|---|---|
| Purpose | Retrieves device enforcement action records for monitoring regulatory actions. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getDeviceEnforcement with search=report_date:[20040101+TO+20131231]&limit=5, then process the results for reporting, research, or compliance. |
Device Adverse Events
| Action | getDeviceEvents |
|---|---|
| Purpose | Retrieves adverse event records for medical devices for safety monitoring. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getDeviceEvents with search=date_received:[20130101+TO+20141231]&limit=5, then process the results for reporting, research, or compliance. |
Premarket Approval (PMA)
| Action | getDevicePma |
|---|---|
| Purpose | Retrieves Premarket Approval (PMA) records for medical devices. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getDevicePma with search=decision_code:APPR&limit=5, then process the results for reporting, research, or compliance. |
Device Recalls
| Action | getDeviceRecalls |
|---|---|
| Purpose | Retrieves device recall records for safety and compliance monitoring. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getDeviceRecalls with search=product_code:FOZ&limit=5, then process the results for reporting, research, or compliance. |
Device Registration & Listing
| Action | getDeviceRegistrationListing |
|---|---|
| Purpose | Retrieves device registration and listing records. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getDeviceRegistrationListing with search=products.product_code:HQY&limit=5, then process the results for reporting, research, or compliance. |
COVID-19 Serology Tests
| Action | getDeviceCovid19Serology |
|---|---|
| Purpose | Retrieves records related to COVID-19 serology tests. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getDeviceCovid19Serology with limit=5, then process the results for reporting, research, or compliance. |
Unique Device Identification (UDI)
| Action | getDeviceUdi |
|---|---|
| Purpose | Retrieves Unique Device Identification (UDI) records for device tracking. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getDeviceUdi with search=_exists_:public_device_record_key&limit=5, then process the results for reporting, research, or compliance. |
Food Enforcement Actions
| Action | getFoodEnforcement |
|---|---|
| Purpose | Retrieves food enforcement action records for food safety monitoring. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getFoodEnforcement with search=report_date:[20040101+TO+20131231]&limit=5, then process the results for reporting, research, or compliance. |
Food Adverse Events
| Action | getFoodEvents |
|---|---|
| Purpose | Retrieves adverse event records related to food products. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getFoodEvents with search=date_started:[20040101+TO+20160101]&limit=5, then process the results for reporting, research, or compliance. |
Historical Documents
| Action | getHistoricalDocuments |
|---|---|
| Purpose | Retrieves historical document records for research and regulatory analysis. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getHistoricalDocuments with search=doc_type:pr+AND+year:1919&limit=5, then process the results for reporting, research, or compliance. |
National Surveillance Data Elements (NSDE)
| Action | getNsde |
|---|---|
| Purpose | Retrieves NSDE records for regulatory data analysis. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getNsde with limit=5, then process the results for reporting, research, or compliance. |
Substance Data
| Action | getSubstance |
|---|---|
| Purpose | Retrieves substance data records for chemical and regulatory analysis. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getSubstance with limit=5, then process the results for reporting, research, or compliance. |
Unique Ingredient Identifier (UNII)
| Action | getUnii |
|---|---|
| Purpose | Retrieves UNII records for ingredient tracking and compliance. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getUnii with limit=5, then process the results for reporting, research, or compliance. |
Tobacco Problem Reports
| Action | getTobaccoProblems |
|---|---|
| Purpose | Retrieves problem reports for tobacco products for regulatory oversight. |
| Parameters | search (optional) – query in field:term format (supports AND/OR, phrase matches, date ranges). limit (optional, 1–1000, default 1). |
| Configuration | Configure the base URL via CONNECTOR_ENV_OPENFDA_BASE_URL (https://api.fda.gov). No API key required. |
| Output | Successful: JSON with results (array of records) and meta (query details and count). Failure: error details (HTTP 400 invalid syntax, 404 invalid fields or no matches). |
| Workflow example | Execute getTobaccoProblems with limit=5, then process the results for reporting, research, or compliance. |
Example Workflow: Drug Safety and Device Compliance Analysis
| Query drug adverse events | Use getDrugEvents with search=receivedate:[20230601+TO+20250601]&limit=10 to identify safety trends. |
|---|---|
| Monitor drug shortages | Execute getDrugShortages with search=shortage_status:Current&limit=5 for supply chain management. |
| Analyze 510(k) clearances | Use getDevice510k with search=advisory_committee:cv&limit=5 for market analysis. |
| Track device adverse events | Execute getDeviceEvents with a date range for post-market surveillance. |
| Enhance reporting with food data | Use getFoodEvents with a date range for public health reports. |
Configuration Notes
| Base URL | Set CONNECTOR_ENV_OPENFDA_BASE_URL to https://api.fda.gov. |
|---|---|
| Error handling | Handle HTTP 400 (invalid syntax) and 404 (invalid fields or no matches) gracefully; check the response body for error details. |
| Search fields | Valid fields for the search parameter vary by endpoint — consult the openFDA documentation (open.fda.gov/apis) for dataset-specific fields. |
| Rate limits | The openFDA API may impose rate limits for high-volume usage; monitor response headers and implement retry logic if needed. |
Support
For technical support, contact custom-connectors-support@isolutions.sa.