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fda_ai_assessment

Evaluate FDA regulatory requirements for AI/ML-based Software as a Medical Device (SaMD). Classify the device, determine regulatory pathway, and ensure compliance per FDA AI/ML Action Plan.

Instructions

Evaluate FDA regulatory requirements for AI/ML-based Software as a Medical Device (SaMD). Determines device classification, regulatory pathway, and compliance requirements per FDA AI/ML Action Plan.

Input Schema

TableJSON Schema
NameRequiredDescriptionDefault
system_nameYesName of the AI medical device or SaMD
intended_useYesIntended use statement for the AI system
ai_model_typeYesType of AI model (e.g., static, adaptive, continuous learning, reinforcement learning)
clinical_contextYesClinical context (e.g., diagnosis, treatment, screening, monitoring)
Behavior2/5

Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?

No annotations are provided, so description carries full burden. The description only mentions the tool's function (evaluating requirements) and does not disclose behavioral traits such as whether it is read-only, if it accesses external databases, or any side effects. Minimal transparency beyond the core purpose.

Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.

Conciseness5/5

Is the description appropriately sized, front-loaded, and free of redundancy?

Two concise sentences front-load the verb 'Evaluate' and clearly convey the purpose without superfluous words. Structure is efficient and impactful.

Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.

Completeness4/5

Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?

Description covers the main purpose and mentions outputs (classification, pathway, compliance). However, without an output schema, the description could be stronger by specifying the format of the assessment. It is mostly complete but lacks explicit output details.

Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.

Parameters3/5

Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?

Schema description coverage is 100%, with each parameter having a clear description. The tool description does not add extra meaning beyond the schema; it only indirectly implies use of parameters through the functional description.

Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.

Purpose5/5

Does the description clearly state what the tool does and how it differs from similar tools?

The description clearly states it evaluates FDA regulatory requirements for AI/ML SaMD and determines classification, pathway, and compliance. This distinguishes it from sibling tools (clinical_ai_safety, eu_mdr_compliance, hipaa_ai_assessment) which focus on other regulatory frameworks.

Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.

Usage Guidelines3/5

Does the description explain when to use this tool, when not to, or what alternatives exist?

The description implies usage for FDA AI/ML SaMD assessment but does not explicitly state when to use versus alternatives or when not to use. No direct comparison to siblings, though domain specificity provides implicit guidance.

Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.

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