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RTA Checklist Preparation

Annotate the RTA checklist with page numbers and sections where requirements are addressed in a 510(k).

View Source YAML

---
name: RTA Checklist Preparation
version: 0.1.0
description: Annotate the RTA checklist with page numbers and sections where requirements are addressed in a 510(k).
metadata:
  domain: regulatory
  complexity: low
  tags:
  - submissions
  - rta
  - checklist
  - 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

    FDA RTA Policy


    ## Objective

    Annotate the RTA checklist with page numbers and sections where requirements are addressed in a 510(k).


    ## Output Format

    Annotated checklist with a comment column.'
- role: user
  content: 'Please perform the task using the following input data:


    <input>

    {{input}}

    </input>'
testData:
- input: Draft 510(k) submission and appropriate FDA RTA checklist. (Example data)
  expected: Expected output as per instructions.
evaluators:
- name: Validation Check
  regex: (?i)Verify