Special Controls Decoder

Automatically decode Class II special controls into specific testing requirements, consensus standards, and FDA guidance documents. This free tool saves consultants 2-3 hours per device by translating regulatory language into actionable testing plans.

How It Works

The Special Controls Decoder analyzes device classification to identify requirements:

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Product Code Analysis: Identifies all special controls associated with the device's product code from FDA classification databases, including performance standards, labeling requirements, and testing protocols.
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Testing Requirements Mapping: Translates special control language into specific testing requirements such as biocompatibility testing, sterility validation, software validation, electrical safety, or clinical performance studies.
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Standards Identification: Links special controls to specific consensus standards (ISO, IEC, ASTM, AAMI) that must be met, including version numbers and testing methods.
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Guidance Document Linking: Identifies relevant FDA guidance documents, special controls guidance, and device-specific guidance that must be followed.
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Testing Plan Generation: Creates structured testing requirement checklists organized by testing category (biocompatibility, performance, software, labeling) with regulatory citations.

What It Does

This tool generates comprehensive special controls analysis reports:

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Testing Requirements List: Complete list of all testing requirements derived from special controls, organized by category
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Standards Checklist: All consensus standards that must be met, with purchase links and version information
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Guidance Documents: Relevant FDA guidance documents with links and key requirements extracted
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Testing Plan Template: Structured testing plan framework that can be customized for specific device testing programs
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Exportable Report: Professional PDF report with your branding that can be shared with clients or testing laboratories

⏱️ How It Saves Time

Saves 2-3 hours per device by automating special controls analysis:

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Automated Decoding: Eliminates 1-2 hours of manually interpreting special control language and cross-referencing with FDA databases
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Standards Research: Saves 30-60 minutes of searching for relevant consensus standards and identifying current versions
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Guidance Document Compilation: Automates 30-60 minutes of identifying and compiling relevant FDA guidance documents
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Testing Plan Structure: Provides ready-made testing plan framework, saving 30-60 minutes of document structure creation

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

Perfect For

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FDA 510k consultants preparing testing requirement assessments for Class II devices
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Regulatory teams developing testing plans and identifying required standards
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Firms providing regulatory strategy services to medical device companies
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FDA 510k consultants reviewing client testing programs for completeness

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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.

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