A
license-
qualityB
maintenanceEnables FDA AI/ML SaMD compliance management, including regulatory pathway classification and PCCP template generation.
1
MIT
Constat MCP — FDA Device Evidence Lifecycle
by com.healthai
Server Details
FDA and CMS evidence for AI medical devices: 510(k), postmarket, reimbursement, and compliance.
- Status
- Unhealthy
- Last Tested
- Transport
- Streamable HTTP
- URL
- Server Listing
- Constat — 483 Risk Radar
Glama MCP Gateway
Connect through Glama MCP Gateway for full control over tool access and complete visibility into every call.
MCP client
Glama
MCP server
Full call logging
Every tool call is logged with complete inputs and outputs, so you can debug issues and audit what your agents are doing.
Tool access control
Enable or disable individual tools per connector, so you decide what your agents can and cannot do.
Managed credentials
Glama handles OAuth flows, token storage, and automatic rotation, so credentials never expire on your clients.
Usage analytics
See which tools your agents call, how often, and when, so you can understand usage patterns and catch anomalies.
100% free. Your data is private.
Tool Definition Quality
A4/5.0
Tool DescriptionsA
Average 4/5 across 14 of 14 tools scored. Lowest: 3.2/5.
Server CoherenceA
Disambiguation4/5
Most tools have clearly distinct purposes, e.g., device_evidence_lookup vs device_postmarket_lookup, but cohort_postmarket_stats and evidence_cohort_stats could cause minor confusion despite detailed descriptions. Overall, boundaries are well-defined.
Naming Consistency5/5
All tool names follow a consistent snake_case verb_noun pattern (e.g., device_evidence_lookup, reimbursement_search). The naming is predictable and easy to parse.
Tool Count5/5
With 14 tools covering premarket evidence, postmarket signals, risk, compliance, reimbursement, and more, the count is well-scoped for the FDA device evidence lifecycle. No tools feel redundant or missing.
Completeness5/5
The tool set comprehensively covers the FDA device evidence lifecycle: premarket lookup and search, postmarket stats and search, risk assessment, compliance history, reimbursement pathways, and predicate chain. The inclusion of a vehicle risk tool is a slight outlier but does not create a gap in the core domain.
Claim this connector by publishing a /.well-known/glama.json file on your server's domain with the following structure:
{
"$schema": "https://glama.ai/mcp/schemas/connector.json",
"maintainers": [{ "email": "your-email@example.com" }]
}The email address must match the email associated with your Glama account. Once published, Glama will automatically detect and verify the file within a few minutes.
Control your server's listing on Glama, including description and metadata
Access analytics and receive server usage reports
Get monitoring and health status updates for your server
Feature your server to boost visibility and reach more users
For users:
Full audit trail – every tool call is logged with inputs and outputs for compliance and debugging
Granular tool control – enable or disable individual tools per connector to limit what your AI agents can do
Centralized credential management – store and rotate API keys and OAuth tokens in one place
Change alerts – get notified when a connector changes its schema, adds or removes tools, or updates tool definitions, so nothing breaks silently
For server owners:
Proven adoption – public usage metrics on your listing show real-world traction and build trust with prospective users
Tool-level analytics – see which tools are being used most, helping you prioritize development and documentation
Direct user feedback – users can report issues and suggest improvements through the listing, giving you a channel you would not have otherwise
The connector status is unhealthy when Glama is unable to successfully connect to the server. This can happen for several reasons:
The server is experiencing an outage
The URL of the server is wrong
Credentials required to access the server are missing or invalid
If you are the owner of this MCP connector and would like to make modifications to the listing, including providing test credentials for accessing the server, please contact support@glama.ai.
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