Regulation Q&A Chat

Ask any question about FDA CFR regulations and get instant, AI-powered answers with citations. This free tool saves consultants 1-2 hours per question by providing accurate regulatory information from FDA's regulation database with proper citations to specific CFR sections.

How It Works

The Regulation Q&A Chat uses RAG (Retrieval-Augmented Generation) technology:

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Question Analysis: Analyzes your question using AI to understand the regulatory topic, device type, or specific CFR section you're asking about.
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Regulation Retrieval: Searches FDA's RegulationCard database using semantic vector search to find the most relevant regulations, special controls, and guidance documents related to your question.
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AI-Powered Answer Generation: Uses Gemini AI to generate accurate, comprehensive answers based on the retrieved regulations, ensuring responses are grounded in actual FDA regulations.
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Citation Extraction: Automatically extracts and includes citations to specific CFR sections, FDA guidance documents, and related regulations in every answer.
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Conversation History: Maintains conversation context, allowing follow-up questions and deeper exploration of regulatory topics.

What It Does

This tool provides comprehensive regulatory Q&A capabilities:

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Instant Answers: Get immediate answers to regulatory questions with proper citations to CFR sections, guidance documents, and special controls
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Related Regulations: Automatically identifies related regulations, guidance documents, and predicate devices that may be relevant to your question
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Conversation Threads: Save and organize conversations by topic, allowing you to build a knowledge base of regulatory Q&A for future reference
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Exportable Reports: Export conversation transcripts with citations as professional PDF reports with your branding for client documentation
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Verification Links: Direct links to eCFR.gov for verifying current regulation text, ensuring you always have access to the most up-to-date information

⏱️ How It Saves Time

Saves 1-2 hours per question by automating regulatory research:

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Instant Regulatory Lookup: Eliminates 30-60 minutes of manually searching through CFR sections and FDA guidance documents to find relevant regulations
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Citation Generation: Saves 15-30 minutes of identifying and formatting proper citations to CFR sections and guidance documents
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Context Understanding: AI understands regulatory context and provides comprehensive answers, saving 15-30 minutes of piecing together information from multiple sources
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Follow-up Questions: Conversation history allows natural follow-up questions without re-explaining context, saving 15-30 minutes per follow-up

ROI: for FDA 510k Consultants asking 10+ regulatory questions per week, this tool saves 10-20 hours monthly while ensuring accurate, cited answers.

Perfect For

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FDA 510k consultants answering client questions about FDA regulations and requirements
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Regulatory teams researching specific CFR sections and regulatory requirements
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Firms building regulatory knowledge bases and training materials
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FDA 510k consultants preparing regulatory strategy documents with proper citations

Get Free Access to Regulation Q&A Chat

This tool is completely free for verified FDA 510k consultants in the Cruxi network. Join thousands of regulatory professionals who use our tools to save 20+ hours per week.

Join 510k Consultant Network (Free)

✓ No subscription fees • ✓ All 15 tools included • ✓ Export with your branding