The Ultimate 510(k) Submission Checklist for 2025

Navigating the FDA 510(k) process requires meticulous attention to detail. A single missing document can lead to a Refuse-to-Accept (RTA) hold, delaying your product launch by months. This checklist outlines every critical component required for a complete and compliant submission.

Section 1: Administrative & Cover Documents

This section ensures your submission is properly identified and routed. Get this wrong, and the FDA won't even begin the review.

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  Medical Device User Fee Cover Sheet (Form FDA 3601): Proof of payment for the 510(k) review fee. This is the very first thing they check.
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  CDRH Premarket Review Submission Cover Sheet (Form FDA 3514): Contains essential information about your company, device, and submission type.
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  510(k) Cover Letter: A formal letter identifying the submission type, device name, and primary contact person.
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  Table of Contents: A clear, paginated guide to the entire submission. The eSTAR template generates this automatically.
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  Indications for Use Statement (Form FDA 3881): A precise, one-paragraph statement defining the intended use of your device. This must exactly match the indications for use in your labeling.
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  Truthful and Accuracy Statement: A legally binding declaration that all information provided is truthful and accurate.

Section 2: Device Description & Predicate Comparison

This is the core of your submission, where you build the argument for Substantial Equivalence (SE).

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  Comprehensive Device Description: Detail the device's design, components, materials, principles of operation, and technical specifications. Include engineering drawings and photos.
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  Predicate Device Identification: Clearly state the 510(k) number(s) for your chosen primary and (if applicable) secondary predicate devices.
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  Substantial Equivalence Comparison Table: A side-by-side table comparing your device to the predicate(s) across Indications for Use, technology, performance, materials, and other key characteristics.
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  Executive Summary / SE Narrative: A summary that explains *why* the differences between your device and the predicate do not raise new questions of safety or effectiveness. Cruxi's AI can help draft this critical narrative.

Section 3: Labeling & Sterilization

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  Draft Labeling: Includes device labels, Instructions for Use (IFU), and any patient labeling. Must be clear, concise, and compliant with 21 CFR 801.
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  Sterilization and Shelf Life (if applicable): Full details of the sterilization method, validation protocols (e.g., ISO 17665, ISO 11135), and data supporting the claimed shelf life.
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  Biocompatibility (if applicable): A declaration of conformity to ISO 10993 and a summary of all biocompatibility testing performed based on the nature and duration of patient contact.

Section 4: Software & Performance Data

Provide objective, scientific evidence that your device performs as intended and is safe for use.

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  Software/Cybersecurity Documentation (for SaMD or software-controlled devices): Documentation level depends on the Level of Concern. Must address architecture, risk analysis (ISO 14971), and cybersecurity threats.
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  Bench Performance Testing: Protocols and results for all non-clinical tests that support the performance claims of your device (e.g., electrical safety, mechanical strength).
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  Animal or Clinical Data (if required): Not always necessary for a 510(k), but if performance differences from the predicate require it, full study protocols and results must be included.

Frequently Asked Questions (FAQ)