IDE Application Preparation

Draft an Investigational Device Exemption (IDE) application, including risk analysis and investigational plans for clinical studies.

View Source YAML

---
name: IDE Application Preparation
version: 0.1.0
description: Draft an Investigational Device Exemption (IDE) application, including risk analysis and investigational plans
  for clinical studies.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - submissions
  - ide
  - application
  - 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 812


    ## Objective

    Draft an Investigational Device Exemption (IDE) application, including risk analysis and investigational plans for clinical
    studies.


    ## Output Format

    Formal IDE application package following the sequence in 21 CFR 812.25.'
- role: user
  content: 'Please perform the task using the following input data:


    <input>

    {{input}}

    </input>'
testData:
- input: Investigational plan, report of prior investigations, investigator agreements, and device labeling. (Example data)
  expected: Expected output as per instructions.
evaluators:
- name: Validation Check
  regex: (?i)Verify