Constat alternative
Constat, from Health AI, is an evidence product for FDA AI/ML-enabled medical devices. It parses 510(k) summaries and predicate chains, tracks MAUDE and recall signals, traces reimbursement pathways, and checks warning letters and Form 483 citations by device product code or firm. Its console and MCP server are free to search without an account; analyst assessments and monitored briefs are paid. RegDataLab does a different job: the public FDA compliance record of a company and its sites, for drug and device manufacturers alike, with inspection outcomes, import alerts and debarments included. If your question is about 510(k) evidence or device reimbursement, Constat is the stronger fit. If you are checking a supplier or a manufacturer, RegDataLab holds more of the record.
No key needed for the check. For the full record, connect RegDataLab or use the API.
Side by side
| Constat | RegDataLab | |
|---|---|---|
| Built for | FDA AI/ML-enabled medical devices | Company and site compliance records, drugs and devices |
| Free access | Public console and MCP server, no account | Free tier with an account |
| Paid options (November 2026) | Analyst assessment from $5,000; monitored brief from $500 a month | Self-serve monthly plans |
| 510(k) records | Parsed summaries, validation evidence and predicate chains | 510(k) and PMA decision records, without summaries |
| MAUDE device adverse event signals | Yes | No |
| Reimbursement pathways (CMS) | Yes | No |
| Warning letters and recalls | Yes | Yes |
| Form 483 citations | Yes, by product code or firm | Yes, by company and site, plus the 483 documents FDA has published |
| Inspection outcomes (NAI, VAI, OAI) | Not listed on its site | Yes |
| Import alerts, import refusals, debarments | Not listed on its site | Yes |
| Drug manufacturing sites | Not its focus | Yes |
| Use in Claude, ChatGPT, Cursor | MCP server | MCP server, plus a REST API |
When to use which
Use Constat when
You work on an AI or software medical device and need predicate devices, the validation evidence FDA accepted, MAUDE trends or a payment pathway.
Use RegDataLab when
You are checking a supplier, contract manufacturer or competitor and want its inspections, 483s, warning letters, recalls and import history together.
Drugs as well as devices
RegDataLab covers drug establishments, drug approvals, labels and shortages next to the device records, matched to the same company family.
Public records, linked to the source
Every record links back to its fda.gov page, so an answer can be checked against FDA's own copy.
Ask it in Claude or ChatGPT
- Check [supplier]'s FDA record: inspections, Form 483s, warning letters and recalls.
- List [company]'s sites with an OAI inspection in the last five years.
- Is [manufacturer] on an FDA import alert, and were any shipments refused?
50 credits now, 300 credits a month once you verify your email.
Questions
- Is RegDataLab a full replacement for Constat?
- No. Constat parses 510(k) summaries, follows predicate chains, trends MAUDE reports and traces reimbursement for AI/ML-enabled devices. RegDataLab does not. RegDataLab covers the compliance record of companies and sites: inspections, Form 483s, warning letters, recalls, import alerts and debarments, for drugs and devices.
- How much does Constat cost?
- Constat's pricing page (November 2026) lists free search in its public console and MCP server, an evidence assessment from $5,000, a monitored evidence brief from $500 a month, and usage-based data access by contact.
- Does RegDataLab cover drug manufacturers?
- Yes. RegDataLab covers drug and device establishments, with inspection outcomes, citations, warning letters, recalls and import records matched to each company and its FEI numbers.
- Is there a free version of RegDataLab?
- Yes. 50 credits now, 300 credits a month once you verify your email.
- How do I use RegDataLab in Claude or ChatGPT?
- Add https://www.regdatalab.com/mcp as a custom connector (Claude: Customize, Connectors, Add custom connector; ChatGPT: Plugins, Add, Add custom MCP server, Authentication OAuth), sign in with your key, then ask in plain English. 50 credits now, 300 credits a month once you verify your email.
- Is RegDataLab part of the FDA?
- No. RegDataLab is an independent data product built on public FDA records. It is not affiliated with, endorsed by, or sponsored by the U.S. Food and Drug Administration.
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