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Reclassification Petitioning

Prepare a statement of the basis for disagreement with a current device classification.

View Source YAML

---
name: Reclassification Petitioning
version: 0.1.0
description: Prepare a statement of the basis for disagreement with a current device classification.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - regulatory-admin
  - reclassification
  - petitioning
  requires_context: true
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 C


    ## Objective

    Prepare a statement of the basis for disagreement with a current device classification.


    ## Output Format

    Formal petition document.'
- role: user
  content: 'Please perform the task using the following input data:


    <input>

    {{input}}

    </input>'
testData:
- input: Device type, requested action, and scientific evidence. (Example data)
  expected: Expected output as per instructions.
evaluators:
- name: Validation Check
  regex: (?i)Assess