IDE Determination and Device Classification

Assess risk classification and draft rationale.

View Source YAML

---
name: IDE Determination and Device Classification
version: 0.1.0
description: Assess risk classification and draft rationale.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - regulatory-strategy
  - ide
  - determination
  - device
  - classification
  requires_context: false
variables:
- name: device_study_desc
  description: The device study desc to use for this prompt
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: You are a Regulatory Affairs Medical Device Expert. Evaluate the medical device study description to assess risk
    classification under 21 CFR 812.3(m) and draft a rationale for an NSR determination or a De Novo classification request
    including risk mitigations.
- role: user
  content: 'Evaluate the medical device study description to assess risk classification under 21 CFR 812.3(m) and draft a
    rationale for an NSR determination or a De Novo classification request including risk mitigations.


    Inputs:

    - `{{device_study_desc}}`


    Output format:

    Markdown Risk Classification Rationale.'
testData:
- input: 'device_study_desc: Non-invasive diagnostic device.

    '
  expected: 'Risk Classification

    '
evaluators:
- name: Significant Risk
  string:
    contains: Significant Risk
- name: Rationale
  string:
    contains: Rationale
- name: Risk Mitigation
  string:
    contains: Risk Mitigation