510(k) Exemption Checker

How It Works

The 510(k) Exemption Checker analyzes your device information to determine exemption status:

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  Product Code Analysis: Checks the device's product code against FDA's exemption database to identify Class I devices that are exempt from 510(k) requirements under 21 CFR 862-892.
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  Regulation Number Verification: Validates the regulation number (21 CFR Part) to determine if the device falls under exempt categories such as pre-amendment devices, custom devices, or investigational devices.
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  Intended Use Assessment: Evaluates the device's intended use to identify exemptions based on specific use cases, patient populations, or clinical applications that may qualify for exemption.
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  Special Exemption Rules: Checks for special exemption scenarios including veterinary devices, research use only (RUO) devices, investigational devices (IDE), and devices intended for export only.
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  Instant Results: Provides immediate exemption status with regulatory citations, explanation of exemption basis, and next steps if 510(k) is required.

What It Does

This tool provides a comprehensive exemption analysis report:

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  Exemption Status: Clear determination of whether the device is exempt from 510(k) or requires submission, with regulatory basis
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  Regulatory Citations: Specific CFR sections, FDA guidance documents, and classification regulations that support the exemption determination
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  Exemption Conditions: Detailed explanation of exemption criteria met and any conditions that must be maintained to remain exempt
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  Next Steps Guidance: Actionable recommendations including whether to proceed with marketing, file a 513(g) request for confirmation, or prepare for 510(k) submission
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  Exportable Report: Professional PDF report with your branding that can be shared with clients or included in regulatory documentation

Perfect For

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  FDA 510k consultants performing initial regulatory assessments for new client devices
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  Regulatory teams evaluating product portfolios for exemption status
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  Firms providing quick regulatory consultations to medical device companies
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  FDA 510k consultants preparing regulatory strategy documents and pathway assessments

Need a regulatory expert?

If you want a second opinion on exemption status or pathway strategy, compare providers in the Cruxi directories hub.