De Novo Request Preparation

Generate a summary of risks and mitigations for a De Novo classification request.

View Source YAML

---
name: De Novo Request Preparation
version: 0.1.0
description: Generate a summary of risks and mitigations for a De Novo classification request.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - submissions
  - novo
  - request
  - preparation
  requires_context: false
variables:
- name: input
  description: The primary input or query text for the prompt
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.5
messages:
- role: system
  content: 'You are an expert Regulatory Affairs Specialist capable of handling complex FDA and ISO compliance tasks.


    ## Context

    21 CFR Part 860 Subpart D


    ## Objective

    Generate a summary of risks and mitigations for a De Novo classification request.


    ## Output Format

    Structured table or list.'
- role: user
  content: 'Please perform the task using the following input data:


    <input>

    {{input}}

    </input>'
testData:
- input: Probable risks and proposed mitigation measures. (Example data)
  expected: Expected output as per instructions.
evaluators:
- name: Validation Check
  regex: (?i)Review