# openFDA

**Canonical:** https://apis.io/providers/open-fda/  
**Website:** https://open.fda.gov/  
**APIs profiled:** 17

openFDA is the FDA's open data platform providing REST APIs for public access to FDA regulatory datasets. It covers drug adverse events (FAERS), drug labeling (SPL), drug recall enforcement reports, medical device 510(k) clearances, device adverse event reports, device recalls and classifications, food recall enforcement actions, food adverse events (CAERS), tobacco problem reports, tobacco research datasets, historical FDA documents, and substance data. All data is returned as JSON and is available free of charge with or without an API key.

## Kin Score — 27.0 / 100 (thin)

Scored 2026-08-21 under rubric 0.12.0. Trend: flat (+0.0 from 27.0).

| Facet | Score |
|---|---|
| Discoverability | 74.1 |
| Contract Quality | 15.5 |
| Governance | 7.6 |
| Contract Governance | 7.6 |
| Operational Transparency | 21.1 |
| Developer Ergonomics | 23.8 |
| Commercial Clarity | 28.9 |
| Access Clarity | 28.9 |

Regulatory layer — **Government & Public Sector**: 31.5 (matched via tags).

## Agent readiness — 11.5 (agent-aware)

| Dimension | Value |
|---|---|
| Spec Presence | no |
| Agentic Access | no |
| Reversibility Documented | no |
| MCP Server | no |
| Auth Clarity | yes |
| Idempotency | no |
| Error Semantics | no |
| OpenAPI Examples | no |
| Rate Limit Signal | documented |
| Event Surface Described | no |
| Agent Skills | no |
| Well Known Catalog | no |
| Consent Identity | no |
| Agent Card | no |
| Dry Run Mode | no |

## Access

Free · Open access — onboarding: open, pricing: free, trial: no (confidence: medium).

## APIs (17)

- **Drug Adverse Events API** — Access FDA Adverse Event Reporting System (FAERS) data covering adverse event reports for drugs and therapeutic biologic products from 2004 onward, updated quarterly.
- **Drug Labeling API** — Access FDA Structured Product Labeling (SPL) files for prescription and over-the-counter drug products, including indications, adverse reactions, and safety information. Updated...
- **Drug Recall Enforcement Reports API** — Access drug product recall enforcement reports submitted to the FDA.
- **Medical Device 510(k) Clearances API** — Access 510(k) premarket notification data demonstrating that devices are at least as safe and effective as legally marketed predicate devices.
- **Medical Device Adverse Event Reports API** — Access reports of serious injuries, deaths, malfunctions, and other undesirable effects associated with the use of medical devices.
- **Medical Device Classification API** — Access medical device names, product codes, specialty areas, and classification data.
- **Medical Device Recall Enforcement Reports API** — Access medical device product recall enforcement report data.
- **Medical Device Premarket Approval (PMA) API** — Access FDA scientific and regulatory review data for Class III medical devices requiring premarket approval.
- **Medical Device Recalls API** — Access actions taken to address problems with medical devices that violate FDA law.
- **Medical Device Registrations and Listings API** — Access establishment locations and corresponding manufactured device listings.
- **Unique Device Identifier (UDI) API** — Access Global Unique Device Identification Database (GUDID) information for medical devices.
- **Food Recall Enforcement Reports API** — Access food product recall enforcement report data from the FDA.
- **Food Adverse Event Reports API (CAERS)** — Access FDA CFSAN Adverse Event Reporting System (CAERS) data for food, dietary supplement, and cosmetic adverse event reports.
- **Tobacco Problem Reports API** — Access reports about tobacco products that are damaged, defective, contaminated, or cause undesirable health effects.
- **Tobacco Research Datasets API** — Access tobacco prevention advertising and smokefree campaign research datasets examining advertising influence on youth attitudes and public health impact.
- **Historical FDA Documents API** — Access FDA press releases from 1913 to 2014 in searchable format.
- **Substance Data API** — Access molecular-level substance information designed for internal and external applications, including the Unique Ingredient Identifier (UNII) listing.

## Security (1)

- **Open Fda Domain Security** — TLSv1.3 · HSTS · DNSSEC · DMARC

## Plans (1)

- **Open Fda Plans Pricing**

## Tags

FDA, Food and Drug Administration, Drug Safety, Adverse Events, Drug Labels, Recalls, Medical Devices, Food Safety, Tobacco, Public Health, Open Data, Government, Regulatory, FAERS, SPL

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Profiled by [API Evangelist](https://apievangelist.com) and published on [APIs.io](https://apis.io/providers/open-fda/). Scores are computed from the provider's own public artifacts under a published rubric.