Analyze software against FDA Clinical Decision Support (CDS) 4-criteria to determine if it qualifies for the CDS exemption under the 21st Century Cures Act Section 3060. When to use: When you need to assess whether a software product requires FDA clearance/approval or qualifies as exempt CDS. Eva...
Part of the Orchestraprime server.
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AI agents call check_cds_classification to retrieve information from Orchestraprime without modifying any data. This is common in research, monitoring, and reporting workflows where the agent needs context before taking action. Because read operations don't change state, they are generally safe to allow without restrictions -- but you may still want rate limits to control API costs.
Even though check_cds_classification only reads data, uncontrolled read access can leak sensitive information or rack up API costs. An agent caught in a retry loop could make thousands of calls per minute. A rate limit gives you a safety net without blocking legitimate use.
Read-only tools are safe to allow by default. No rate limit needed unless you want to control costs.
{
"version": "1",
"default": "deny",
"tools": {
"check_cds_classification": {}
}
}See the full Orchestraprime policy for all 9 tools.
These attack patterns abuse exactly the kind of access check_cds_classification gives an agent. Each links to the full case and the policy that stops it:
Other read tools across the catalogue. The same approach applies to each: allow, with a rate cap to control cost.
Analyze software against FDA Clinical Decision Support (CDS) 4-criteria to determine if it qualifies for the CDS exemption under the 21st Century Cures Act Section 3060. When to use: When you need to assess whether a software product requires FDA clearance/approval or qualifies as exempt CDS. Evaluates all 4 criteria: 1. Not intended to acquire/process medical images or signals 2. Intended to display, analyze, or print medical information 3. Intended for healthcare professionals (not patients) 4. Does not provide specific diagnostic/treatment recommendations Classification: EXEMPT (all 4 met) or DEVICE (any criterion failed). It is categorised as a Read tool in the Orchestraprime MCP Server, which means it retrieves data without modifying state.
Register the Orchestraprime MCP server in PolicyLayer and add a rule for check_cds_classification: allow, deny, rate-limit, or require approval. Point your MCP client at the PolicyLayer proxy URL and the rule is enforced on every call, before it reaches Orchestraprime. Nothing to install.
check_cds_classification is a Read tool with low risk. Read-only tools are generally safe to allow by default.
Yes. Add a rate_limit block to the check_cds_classification rule in your PolicyLayer policy. For example, setting max: 10 and window: 60 limits the tool to 10 calls per minute. Rate limits are tracked per agent session and reset automatically.
Set action: deny in the PolicyLayer policy for check_cds_classification. The AI agent will receive a policy violation error and cannot call the tool. You can also include a reason field to explain why the tool is blocked.
check_cds_classification is provided by the Orchestraprime MCP server (@orchestraprime/mcp-server). PolicyLayer sits as a proxy in front of this server to enforce policies before tool calls reach the server.
Deterministic rules across all 9 Orchestraprime tools. Per-identity grants. Full audit log. Live in minutes. Nothing to install.
Free to start. No card required.
4,600+ MCP servers and 31,000+ tools scanned and risk-classified.