openFDA
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.
Limited machine-readable signal and partial portal coverage — documentation a human can read, but little a machine or agent can consume without scraping.
API Evangelist profiles openFDA the way a machine reads it — 41 machine-readable artifacts across 17 APIs, pulled from the provider's own public surface and indexed so a developer, an analyst, or an AI agent can evaluate it against every other provider on the network.
Every provider in the network is reduced to the same set of machine-readable artifacts — OpenAPI contracts, event specifications, GraphQL schemas, runnable collections, pricing and rate-limit signals, security posture, OAuth scopes, and the agent surfaces (MCP servers and skills) that let software drive the API on its own. We profile them because the interface is the part of a company you can actually inspect: it is a truer signal of what a provider does than any marketing page. From those artifacts we compute the Kin Score — openFDA scores 36.1/100 (thin), with a separate agent-readiness read of 16/100 (agent aware). The full breakdown is below, followed by every artifact we hold — each card links through to its machine-readable definition on apis.io.
Kin Score
This is the API Evangelist rating — a single, repeatable read computed from the artifacts on this page. Green fill is points earned; the red track is points possible, so every bar shows earned-versus-possible at a glance.
Kin Score
How this is scored →scored 2026-07-27 · rubric v0.5
How we profile openFDA
Each block below is one kind of artifact we hold for openFDA. For each we say what it is and why it earns a place in the profile, then list every one we've indexed — capped at two rows, scroll within the panel for the rest.
APIs 17
Each API is captured as its own OpenAPI definition — every operation, parameter, and response. This is the single most useful machine-readable description of what an API does, and it's what lets us score, lint, mock, and generate against it without asking the provider for anything.
Individual APIs this provider publishes, each with its own machine-readable definition.
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.
Scroll within the panel for all 17 ·
Pricing Plans 1
Pricing is part of the interface. Machine-readable plans tell you what a tier costs and includes before you commit — one of the six things the Kin Score reads for commercial clarity.
Published pricing tiers and plan structures.
Rate Limits 1
Rate limits are the difference between a demo that works and a production integration that doesn't fall over. Publishing them is an operational-transparency signal — and a hard requirement for any agent that plans its own throughput.
Documented rate limits and quota policies.
Open Fda Rate Limits
RATE LIMITSFinOps 1
Cost, billing, and metering signals let a buyer model the financial operations of an API before it's live. We profile them for the same reason we profile pricing: the money is part of the contract.
Cost, billing, and metering signals for API financial operations.
Open Fda Finops
FINOPSSemantic Vocabularies 1
JSON-LD contexts give the data shared meaning across APIs. We profile them because semantics are what let a machine reconcile 'customer' here with 'customer' somewhere else.
JSON-LD contexts and semantic vocabularies used across these APIs.
Open Fda Context
JSON-LDSpectral Rules 1
Governance rulesets we run against this provider's specs — the automated checks behind parts of the score. Profiling them makes the quality bar explicit and re-runnable, not a matter of opinion.
openFDA API Rules
SPECTRALJSON Schema 8
Standalone JSON Schema definitions describe the data models behind the API. We profile them so the shapes are validatable on their own — useful long after a single request is forgotten.
Standalone JSON Schema definitions for this provider's data models.
Device 510K Clearance
JSON SCHEMADevice Adverse Event
JSON SCHEMADrug Adverse Event
JSON SCHEMADrug Label
JSON SCHEMAEnforcement Recall
JSON SCHEMAFood Adverse Event
JSON SCHEMASubstance Data
JSON SCHEMATobacco Problem
JSON SCHEMAScroll within the panel for all 8 ·
Examples 10
Real request and response payloads are what turn a spec from abstract into obvious — and they're one of the twelve things an agent needs to call an API correctly on the first try.
Example request and response payloads for these APIs.
Device 510K
EXAMPLEDevice Adverse Event
EXAMPLEDevice Classification
EXAMPLEDrug Adverse Event
EXAMPLEDrug Enforcement Recall
EXAMPLEDrug Label
EXAMPLEFood Adverse Event
EXAMPLEFood Enforcement Recall
EXAMPLESubstance Data
EXAMPLETobacco Problem
EXAMPLEScroll within the panel for all 10 ·
Security Posture 1
Authentication, domain security, vulnerability disclosure, and trust-center signals — the evidence that a provider takes security seriously enough to document it. We profile it because you can't govern what you can't see.
Authentication, domain security, vulnerability disclosure, and trust-center signals.
Resources
Every other property we hold for openFDA — documentation, portals, status pages, policies, and corporate surface — grouped by the job it does, following the integrator's arc from getting started to running in production.
Documentation 1
Reference material describing how the API behaves
Build 2
SDKs, sample code, and the tooling you integrate with
Access & Security 2
Authentication, authorization, and security posture
Operate 2
Status, limits, changes, and where to get help
Commercial 2
Pricing, plans, and the legal terms of use
Company 2
The organization behind the API
Other 1
Properties that don't map to a standard resource type
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