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Correction and Removal Reporting

Draft a written report to FDA for a device correction or removal.

View Source YAML

---
name: Correction and Removal Reporting
version: 0.1.0
description: Draft a written report to FDA for a device correction or removal.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - compliance
  - correction
  - removal
  - reporting
  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 806


    ## Objective

    Draft a written report to FDA for a device correction or removal.


    ## Output Format

    Formal report following 21 CFR 806.10(c)(1).'
- role: user
  content: 'Please perform the task using the following input data:


    <input>

    {{input}}

    </input>'
testData:
- input: UDI, event description, and consignee list. (Example data)
  expected: Expected output as per instructions.
evaluators:
- name: Validation Check
  regex: (?i)Cross\-check