Guidance Pack Builder

Automatically compile curated FDA guidance documents and consensus standards specific to your device type. This free tool saves consultants 2-3 hours per device by identifying and organizing all relevant guidance documents, special controls guidance, and consensus standards in one comprehensive pack.

How It Works

The Guidance Pack Builder compiles device-specific regulatory resources:

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Device-Specific Guidance: Identifies all FDA guidance documents relevant to the device type, product code, and regulatory pathway, including device-specific guidances, general guidances, and special controls guidance.
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Consensus Standards Compilation: Compiles all consensus standards (ISO, IEC, ASTM, AAMI) recognized by FDA for the device type, including current versions and testing requirements.
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Regulatory Pathway Guidance: Includes guidance documents specific to the regulatory pathway (510(k), De Novo, PMA) and submission type, ensuring comprehensive coverage of applicable requirements.
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Document Organization: Organizes guidance documents and standards by category (testing, labeling, software, clinical evaluation, etc.) for easy reference and navigation.
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Direct Links: Provides direct links to FDA guidance documents and standards organizations for easy access and download.

What It Does

This tool generates comprehensive guidance packs:

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Guidance Document List: Complete list of all relevant FDA guidance documents with titles, publication dates, and direct links
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Standards Catalog: All applicable consensus standards with version numbers, recognition status, and purchase links
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Organized Categories: Guidance documents and standards organized by regulatory topic for easy reference
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Key Requirements Summary: Summary of key requirements from each guidance document to help consultants quickly identify applicable requirements
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Exportable Pack: Professional PDF guidance pack with your branding that can be shared with clients or used as a reference document

⏱️ How It Saves Time

Saves 2-3 hours per device by automating guidance compilation:

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Automated Guidance Identification: Eliminates 1-2 hours of manually searching FDA guidance databases to identify relevant documents for specific device types
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Standards Compilation: Saves 30-60 minutes of compiling consensus standards from FDA's recognized standards database
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Document Organization: Automates 30-60 minutes of organizing guidance documents and standards into logical categories
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Link Compilation: Provides ready-made document with direct links, saving 15-30 minutes of finding and formatting links

ROI: for FDA 510k Consultants handling 10+ devices per month, this tool saves 20-30 hours monthly while ensuring comprehensive guidance document coverage.

Perfect For

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FDA 510k consultants preparing regulatory strategy documents and guidance compilations for clients
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Regulatory teams building reference libraries for specific device types or regulatory pathways
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Firms providing regulatory consulting services with comprehensive guidance document support
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FDA 510k consultants onboarding new clients and providing regulatory resource packs

Get Free Access to Guidance Pack Builder

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