PMA Post-approval Reporting

Compile a summary of post-approval requirements, including clinical study data, manufacturing changes, and scientific literature.

View Source YAML

---
name: PMA Post-approval Reporting
version: 0.1.0
description: Compile a summary of post-approval requirements, including clinical study data, manufacturing changes, and scientific
  literature.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - submissions
  - pma
  - post-approval
  - 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 814.82 / 814.84


    ## Objective

    Compile a summary of post-approval requirements, including clinical study data, manufacturing changes, and scientific
    literature.


    ## Output Format

    Formal report to the Office of Device Evaluation.'
- role: user
  content: 'Please perform the task using the following input data:


    <input>

    {{input}}

    </input>'
testData:
- input: PMA approval order, study data, change logs, and bibliography of recent literature. (Example data)
  expected: Expected output as per instructions.
evaluators:
- name: Validation Check
  regex: (?i)Verify