FDA GUDID Device Monitor: UDI Distribution Status Alerts

Watch a book of Primary Device Identifiers (DIs) and emit typed events when NLM AccessGUDID shows a DI flipping In Commercial Distribution ↔ Not in Commercial Distribution, changing material deviceRecordStatus / publicVersion*, appearing, or dropping from lookup.

Who this is for: Medical device distributors and GPOs, hospital supply-chain / value-analysis teams, UDI data managers and regulatory-affairs consultants. The recurring job: tell me when a device on my formulary or catalogue is no longer in commercial distribution, or its GUDID record changes.

Quick start

1. Put your Primary DIs in primaryDis (example: 00848486000400).
2. Set sourceMode = live.
3. Save as an Actor Task and schedule it weekly (GUDID records change continuously).
4. First run vs later runs: run 1 stores a baseline for each key (no change events, no product charge). Run 2+ emits only real changes. Keep the same Task so the baseline persists.

Default sourceMode=fixture is a free health check (one non-billable RUN_STATUS row), not product data. You pay $0.02 only per delivered unique change event; quiet books cost only the platform start fee.

Scope: a watchlist monitor, not a bulk dump. You are billed per delivered change on your own keys, never per national row.

Coverage honesty

• Source: NLM AccessGUDID APIs — https://accessgudid.nlm.nih.gov/api/v2/devices/lookup.json?di={DI} (+ optional history). Default provenance AccessGUDID.
• Keys: Primary DI exact match after normalize (digits; leading zeros preserved).
• Scope: Commercial-distribution / record/version status only — do not claim recalls, adverse events, 510(k)/PMA outcomes, or Canadian MDALL licences.

Events

Event	When
DISTRIBUTION_STATUS_CHANGED	deviceCommDistributionStatus / commercialDistributionStatus changed
RECORD_STATUS_CHANGED	deviceRecordStatus and/or publicVersion* changed
APPEARED	Watched DI missing → present in AccessGUDID
DROPPED	Watched DI present → missing from AccessGUDID
RUN_STATUS	Non-billable health row every successful run

First observation = baseline only (no product charge).

Modes

• sourceMode=fixture (default): Store health → RUN_STATUS / FIXTURE_HEALTH only unless emitFixtureDemoEvents=true.
• sourceMode=live: AccessGUDID lookup per watched DI (no paid key).

Pricing (pay per event)

• gudid-di-status-event-delivered @ $0.02
• apify-actor-start @ $0.00005

Legal

Official public data — AccessGUDID / FDA public device identification data. Cite NLM AccessGUDID + retrieval date. Do not claim patient-level UDI/PI surveillance.

Private

isPublic must remain false for this launch.