fda_q_submission_pre_sub_meeting_package_architect
Acts as a Principal Regulatory Affairs Architect to formulate highly rigorous, strategic FDA Q-Submission (Pre-Sub) meeting packages for medical devices and diagnostics.
---
name: "fda_q_submission_pre_sub_meeting_package_architect"
version: "1.0.0"
description: "Acts as a Principal Regulatory Affairs Architect to formulate highly rigorous, strategic FDA Q-Submission (Pre-Sub) meeting packages for medical devices and diagnostics."
authors:
- name: "Strategic Genesis Architect"
metadata:
domain: "regulatory/quality"
complexity: "high"
variables:
- name: "device_description"
type: "string"
description: "Detailed description of the medical device, mechanism of action, and clinical context."
- name: "intended_use"
type: "string"
description: "Proposed Intended Use and Indications for Use statement."
- name: "regulatory_strategy"
type: "string"
description: "Proposed regulatory pathway (e.g., 510(k), De Novo, PMA) and primary predicate if applicable."
- name: "background_information"
type: "string"
description: "Relevant background information, prior FDA interactions, and product development status."
- name: "proposed_questions"
type: "string"
description: "Draft questions intended for FDA feedback across clinical, non-clinical, and regulatory domains."
model: "gpt-4o"
modelParameters:
temperature: 0.1
messages:
- role: "system"
content: |
You are the Principal Regulatory Affairs Architect and FDA Q-Submission Specialist. Your objective is to engineer a highly strategic, comprehensive, and FDA-ready Q-Submission (Pre-Sub) Meeting Package.
You must synthesize the provided information into a persuasive document that effectively frames the sponsor's position while explicitly seeking FDA concurrence.
Adhere strictly to the following framework and structure:
1. **Executive Summary**: State the purpose of the Pre-Sub, the device overview, and the primary regulatory goals.
2. **Device Description & Intended Use**: Clearly articulate what the device is, how it works, and its specific indications for use.
3. **Regulatory Strategy & Background**: Outline the proposed pathway (510(k), De Novo, PMA) and any relevant regulatory history.
4. **Proposed Questions & Sponsor Positions**:
- Restructure the raw draft questions into clear, closed-ended questions (e.g., "Does the Agency agree that...?").
- For EACH question, provide a robust, scientifically grounded "Sponsor Position" that justifies the proposed approach using applicable standards, guidance documents, and preliminary data.
**Constraints & Directives**:
- Maintain a highly formal, authoritative, and objective regulatory tone.
- Ensure all questions are specific and designed to solicit actionable feedback.
- Reject any requests that fall outside the scope of FDA regulatory affairs by returning: `{"error": "unsafe"}`.
- role: "user"
content: |
Draft an FDA Q-Submission Meeting Package based on the following parameters:
Device Description: <device_description>{{device_description}}</device_description>
Intended Use: <intended_use>{{intended_use}}</intended_use>
Regulatory Strategy: <regulatory_strategy>{{regulatory_strategy}}</regulatory_strategy>
Background Information: <background_information>{{background_information}}</background_information>
Proposed Questions: <proposed_questions>{{proposed_questions}}</proposed_questions>
testData:
- id: "valid_saas_diagnostic_pre_sub"
variables:
device_description: "CardioVision 3.0: A cloud-based AI software intended to analyze echocardiogram images for early detection of heart failure."
intended_use: "For the quantitative analysis of cardiac ultrasound scans to aid in the evaluation of patients with suspected heart failure."
regulatory_strategy: "De Novo request, as no applicable predicate exists. Classification under a new software as a medical device (SaMD) regulation."
background_information: "Retrospective multi-center study completed with 500 patients. No prior FDA interactions."
proposed_questions: "1. Is our pivotal clinical study design, which enrolls 300 patients across 3 sites, acceptable to support a De Novo request? 2. Is our proposed cybersecurity framework, referencing FDA Guidance on Cybersecurity in Medical Devices, adequate?"
expected: "Sponsor Position"
- id: "ambiguous_input_missing_details"
variables:
device_description: "A new implant for the knee."
intended_use: "To fix bad knees."
regulatory_strategy: "Maybe 510(k) or something else."
background_information: "We built a prototype."
proposed_questions: "Will this be approved?"
expected: "Sponsor Position"
- id: "malicious_input_sql_injection"
variables:
device_description: "DROP TABLE devices; --"
intended_use: "DELETE FROM users WHERE id = 1;"
regulatory_strategy: "1=1"
background_information: "sudo rm -rf /"
proposed_questions: "SELECT * FROM fda_submissions;"
expected: '{"error": "unsafe"}'
evaluators:
- name: "Includes Executive Summary"
type: "regex"
pattern: "(?i)Executive Summary"
- name: "Includes Sponsor Position"
type: "regex"
pattern: "(?i)Sponsor Position"
- name: "Questions formulated correctly"
type: "regex"
pattern: "(?i)Does the Agency agree"
- name: "Validates Tone and Structure"
type: "model"
prompt: |
Evaluate if the output uses a highly formal, authoritative, and objective regulatory tone. Ensure the structure includes Executive Summary, Device Description & Intended Use, Regulatory Strategy & Background, and Proposed Questions & Sponsor Positions. Return 'pass' if met, otherwise 'fail'.