Constat · Medical-device regulatory intelligence
FDA device evidence for teams— scoped to the decision.
Search the public console and FDA MCP server for free. When a regulatory, quality, postmarket, or market-access decision needs a defined deliverable, add a bounded assessment, configured monitoring, or licensed higher-volume access.
Free evidence access; paid work begins with scope
Public console + anonymous MCP
Search source-linked 510(k) evidence, postmarket signals, reimbursement pathways, and FDA compliance records. Anonymous MCP reads are rate-limited; no credit card is required.
$0
Evidence Assessment
From $5kone-time
A bounded, source-linked review built around one decision: 510(k) precedent, validation evidence, postmarket and compliance context, reimbursement pathways, or an agreed combination.
2-week target after scope is confirmed
Monitored Evidence Brief
From $500/month
A configured watchlist for agreed product codes, firms, competitors, or suppliers. Reviewed briefs state what changed, the relevant public source, why it entered review, and what it cannot establish.
Cadence and scope set before monitoring starts
Evidence Data & MCP
Contactusage-based
Higher-volume Constat MCP access and licensed evidence exports for teams integrating FDA and CMS public-record evidence into regulatory, diligence, quality, or market-access workflows.
Usage and license scoped to the workflow
Have a specific device, product code, firm, or market-access question?
Start from the job your team needs to finish
Regulatory affairs
Find similar 510(k) devices, compare predicate chains, and inspect source-quoted validation evidence.
Quality & postmarket
Review MAUDE trends, recalls, warning letters, Form 483 citations, and monitored public-record changes.
Market access
Trace clearances to documented NTAP, CPT or HCPCS identifiers, CMS rates, LCDs, and public payer policies.
Data & agent teams
Query the same evidence over Constat MCP or scope licensed exports for an internal workflow.
How it works
1 · Pipeline
Automated ingestion of recalls, MAUDE, warning letters, and inspection citations for your product codes — refreshed weekly, normalized into one schema.
2 · Review
An analyst checks attribution, preserves the source record, documents why an item entered review, and states what the public evidence cannot establish. No specific enforcement action is predicted.
3 · Deliverable
The agreed assessment or monitored brief links every material statement to its source and keeps assumptions, gaps, and interpretation limits visible.
Warning Letters
fda.gov records normalized by issue date, issuing center, firm, and violation subject, with source links preserved.
Device Recalls
Every recall event with FDA's own root-cause determination — design, software, process, supplier.
MAUDE Adverse Events
Millions of device adverse-event reports, trended by product category to catch acceleration early.
Form 483 Observations
Inspection observations by CFR clause via FDA's Data Dashboard — one category-level signal among several, not a prediction of enforcement.
Questions before you scope
What can I use for free?
The public Constat console and anonymous Constat MCP read tools are free within the published rate limit. Paid work adds a defined analyst deliverable, configured monitoring, higher usage, or licensed exports.
Is an evidence assessment regulatory or reimbursement advice?
No. Constat organizes and interprets bounded public-record evidence with sources, assumptions, and limits. It does not replace legal counsel, a regulatory-affairs signatory, a coding opinion, or a payer coverage determination.
Can Constat monitor a firm, supplier, competitor, or product code?
Yes, after the names, product codes, source coverage, cadence, recipients, and review rules are agreed. Public records do not support every entity join, so attribution limits remain visible.
What does the first scoping conversation establish?
The decision to support, device or category, sources, time window, deliverable, review process, exclusions, data license, and the claims the available evidence can and cannot support.