US FDA Compliance Monitor
Pricing
from $20.00 / 1,000 results
US FDA Compliance Monitor
Monitor the FDA for medical device recalls, 510(k) clearances, PMA approvals, and drug/food enforcement actions, from the official openFDA API. Filter by firm, product, or keyword and date. For regulatory affairs, compliance teams, and competitive intelligence.
Pricing
from $20.00 / 1,000 results
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Developer
Saturnin Pugnet
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0
Bookmarked
2
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1
Monthly active users
2 days ago
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Monitor the FDA for the regulatory events that matter, in one unified feed from the official openFDA API:
- Medical device recalls — who's recalling what, and why
- 510(k) clearances — new devices cleared to market (competitor launch intel)
- PMA approvals — premarket approvals and supplements
- Drug enforcement / recalls — Class I/II/III drug recalls
- Food enforcement / recalls — food safety recalls (allergens, contamination)
Filter by firm, product, or keyword and a date window. Runs as a lightweight HTTP actor — fast and cheap.
Who Uses This
- Medtech / pharma regulatory affairs: track recalls and enforcement across your product codes
- Compliance teams: get alerted to Class I recalls and enforcement actions in your category
- Competitive intelligence: 510(k)/PMA feeds show exactly when competitors get a device cleared
- Food & beverage safety: monitor allergen and contamination recalls
- AI agents: ask "recent recalls for [firm]", "510(k) clearances this month in [category]", "Class I food recalls with allergen X"
Input
| Field | Description |
|---|---|
dataTypes | Which FDA datasets to pull (empty = all): device-recalls, device-510k, device-pma, drug-enforcement, food-enforcement |
searchTerm | Optional keyword filter (firm, product, reason) |
sinceDays | Only records from the last N days |
maxResultsPerType / maxResults | Caps (0 = unlimited) |
Output
Unified schema across all datasets: dataType, signalDate, firm, productName, classification (e.g. Class I), status, reason, productCode, idNumber (recall/K/PMA number), advisoryCommittee, state, country, distributionPattern, sourceUrl, dataSource.
Notes
- Data comes from the official openFDA API. It refreshes every few days (device recalls and 510(k)s are typically current within a week).
- Drug/food enforcement report_date and device event/decision dates drive the date window per dataset.
- Schedule a daily/weekly run to keep a live compliance feed; combine with webhooks for alerts.
Related Actors
- US Business Entity Search - Verify a recalling firm's business registration
- Website Company Enricher - Enrich a firm with contact and company data
