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Intended Use and Indications for Use Alignment

Review 510(k) drafts to ensure 'Intended Use' and 'Indications for Use' are verbatim and consistent.

View Source YAML

---
name: Intended Use and Indications for Use Alignment
version: 0.1.0
description: Review 510(k) drafts to ensure 'Intended Use' and 'Indications for Use' are verbatim and consistent.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - regulatory-adherence
  - intended
  - use
  - indications
  - alignment
  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 801.4


    ## Objective

    Review 510(k) drafts to ensure ''Intended Use'' and ''Indications for Use'' are verbatim and consistent.


    ## Output Format

    Consistency report identifying discrepancies.'
- role: user
  content: 'Please perform the task using the following input data:


    <input>

    {{input}}

    </input>'
testData:
- input: Full 510(k) draft including labeling and executive summary. (Example data)
  expected: Expected output as per instructions.
evaluators:
- name: Validation Check
  regex: (?i)Cross\-reference