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.
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Download Checklist PDFSection 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.
- check_circleMedical 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.
- check_circleCDRH Premarket Review Submission Cover Sheet (Form FDA 3514): Contains essential information about your company, device, and submission type.
- check_circle510(k) Cover Letter: A formal letter identifying the submission type, device name, and primary contact person.
- check_circleTable of Contents: A clear, paginated guide to the entire submission. The eSTAR template generates this automatically.
- check_circleIndications 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.
- check_circleTruthful 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).
- check_circleComprehensive Device Description: Detail the device's design, components, materials, principles of operation, and technical specifications. Include engineering drawings and photos.
- check_circlePredicate Device Identification: Clearly state the 510(k) number(s) for your chosen primary and (if applicable) secondary predicate devices.
- check_circleSubstantial 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.
- check_circleExecutive 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. This critical narrative requires careful analysis of technological characteristics and performance data.
Section 3: Labeling & Sterilization
- check_circleDraft Labeling: Includes device labels, Instructions for Use (IFU), and any patient labeling. Must be clear, concise, and compliant with 21 CFR 801.
- check_circleSterilization 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.
- check_circleBiocompatibility (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 Documentation (IEC 62304)
For devices with software functionality, comprehensive software lifecycle documentation is required.
- check_circleSoftware Safety Classification & Rationale: Determine the Level of Concern (A, B, or C) and justify the classification with clear rationale.
- check_circleSoftware Architecture & Design (SDS/SDD): Detailed software design specification including architecture diagrams, modules, and data flows.
- check_circleSoftware Verification & Validation Summary: Complete V&V protocols, test results, and evidence of software quality assurance.
- check_circleSOUP / OTS & Cyber-Related Components List: Software of Unknown Provenance and Off-The-Shelf components inventory with risk assessments.
- check_circleMaintenance & Configuration Management: Procedures for software updates, version control, and configuration management.
Section 5: Cybersecurity Documentation
Critical for connected devices, software-controlled devices, or any device with network interfaces.
- check_circleThreat Modeling & Security Risk Assessment: Comprehensive threat enumeration, attack vectors, and security risk analysis with mitigations.
- check_circleSBOM (Software Bill of Materials): Complete inventory of all software components, versions, and dependencies.
- check_circleVulnerability Management & Patching Policy: Procedures for identifying, assessing, and addressing security vulnerabilities.
- check_circleAccess Control, Authentication & Logging: Security controls for user access, authentication mechanisms, and audit logging.
Section 6: Bench & Performance Testing
Provide objective, scientific evidence that your device performs as intended and is safe for use.
- check_circleBench Test Summary & Acceptance Criteria: Overview of all performance testing with clear acceptance criteria and pass/fail determinations.
- check_circlePerformance Test Reports: Detailed protocols and results for all non-clinical tests supporting device performance claims.
- check_circleEnvironmental/Stress Tests: Testing under various environmental conditions and stress scenarios.
- check_circlePrecision/Repeatability Testing: Evidence of device precision, accuracy, and repeatability under normal use conditions.
- check_circleInteroperability Testing (if applicable): Testing with external systems, devices, or software platforms.
Section 7: Electrical Safety & EMC
Required for all electrically powered or active devices.
- check_circleElectrical Safety (IEC 60601-1): Complete electrical safety testing including test matrix, results, and any deviations with justifications.
- check_circleEMC (IEC 60601-1-2): Electromagnetic compatibility testing including emission and immunity testing with test matrix and deviation analysis.
Section 8: Biocompatibility (ISO 10993)
Required for any device with patient-contacting materials.
- check_circleBiocompatibility Evaluation & Justification: Complete evaluation following ISO 10993-1 matrix based on contact type and duration.
- check_circleBiocompatibility Test Reports: Cytotoxicity, sensitization, irritation/intracutaneous reactivity, and other applicable tests.
Section 9: Sterilization & Microbiology
Required for devices supplied sterile.
- check_circleSterilization Method & SAL: Detailed sterilization process including cycle parameters and Sterility Assurance Level (SAL).
- check_circleSterilization Validation Reports: Complete validation studies demonstrating sterilization effectiveness.
- check_circlePackaging Sterile Barrier: Validation of packaging integrity and sterile barrier maintenance.
- check_circlePyrogen/Endotoxin Testing: Testing for pyrogenic substances as applicable to the device.
- check_circleResiduals / EO Aeration (if EO sterilized): Testing for ethylene oxide residuals and aeration validation.
Section 10: Reprocessing / Cleaning / Disinfection
Required for reusable devices that require cleaning and disinfection.
- check_circleReprocessing Instructions: Detailed instructions for use including soil selection, worst-case loads, and acceptance criteria.
- check_circleReprocessing Validation: Validation studies demonstrating effective cleaning and disinfection.
Section 11: Packaging Integrity & Shelf Life
Required for devices with sterile packaging or labeled shelf life.
- check_circlePackaging Integrity Validation: Seal strength testing, transit/drop testing, and distribution robustness validation.
- check_circleShelf Life Testing: Aging protocols and results supporting claimed shelf life for sterile and non-sterile devices.
Section 12: Clinical Performance (if applicable)
Required when clinical data is needed to support substantial equivalence.
- check_circleClinical Rationale for SE: Study design, endpoints & statistics, and risk/benefit narrative.
- check_circleClinical Study Reports / Literature: Complete clinical study reports or literature review supporting safety and effectiveness.
Section 13: Human Factors & Usability
Required for devices with use-related risks, home use, or pediatric use.
- check_circleHFE/UE Plan: Human factors engineering plan including use-error analysis (URRA/UFMEA).
- check_circleFormative Study Rounds: Iterative usability testing to identify and resolve use-related issues.
- check_circleSummative (Validation) Study Report: Final validation study demonstrating safe and effective use.
Section 14: Interoperability
Required for devices that interoperate with external systems.
- check_circleInteroperability Description & Standards: Profiles/standards (HL7/FHIR/IEEE) and negative tests/failure modes.
- check_circleInteroperability Testing Evidence: Testing results demonstrating successful interoperability with external systems.
Section 15: Radiation Safety / Emissions
Required for devices that emit radiation.
- check_circleRadiation Emission Safety: Safety evaluation and testing for devices that emit radiation (per 21 CFR 1000-1050).
Section 16: Wireless / RF Compliance
Required for devices with wireless functionality.
- check_circleRF Compliance (FCC/ETSI test reports): Radio frequency compliance testing and certification for wireless devices.
Section 17: MRI Safety (Implantable Devices)
Required for implantable devices or devices labeled as MR Conditional.
- check_circleMRI Safety Evaluation: Testing per ASTM F2503 and other applicable standards for MRI compatibility.
Section 18: Standards & Declarations of Conformity
Required for all devices - comprehensive standards compliance documentation.
- check_circleStandards Applicable Table: Complete conformity matrix showing applicable standards and compliance status.
- check_circleDeviations & Rationales: Any deviations from standards with detailed justifications.
- check_circleDeclarations of Conformity: Formal declarations of conformity to applicable standards.
Section 19: Supporting Documents
Additional documentation that supports the submission.
- check_circleRequirements Traceability Matrix: Traceability from requirements through testing to evidence (for software and performance-critical devices).
- check_circlePhotos / Drawings / Schematics: Device photos, engineering drawings, and technical schematics.
- check_circleUDI/UDID (if applicable): Unique Device Identifier and Universal Device Identification Database information.
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Request Beta AccessFrequently Asked Questions (FAQ)
What is an RTA checklist for a 510(k)?
RTA stands for 'Refuse to Accept.' An RTA checklist is used by the FDA during their initial review to ensure a 510(k) submission is administratively complete. If key documents or sections are missing, the FDA will issue an RTA hold, delaying the substantive review. Our comprehensive checklist covers all 19 major sections to help you pass this initial RTA screening.
How many sections are required for a complete 510(k) submission?
A complete 510(k) submission typically requires 19 major sections covering everything from administrative forms to specialized testing like cybersecurity, interoperability, and MRI safety. The exact requirements depend on your device characteristics - software devices need cybersecurity documentation, implantable devices need MRI safety testing, and reusable devices need reprocessing validation.
How long does it take to prepare a 510(k) submission?
Preparing a 510(k) can take anywhere from 3 to 9 months, depending on the complexity of the device, the availability of predicate data, and the need for performance testing. With 19 major sections and hundreds of specific requirements, using a comprehensive checklist and AI-powered tools like Cruxi can significantly accelerate the preparation phase.
What's the difference between required and conditional sections?
Required sections (like Administrative, SE Core, Device Description) apply to all 510(k) submissions. Conditional sections depend on device characteristics: Software devices need cybersecurity documentation, sterile devices need sterilization validation, reusable devices need reprocessing studies, and devices with patient contact need biocompatibility testing.
Is the eSTAR template required for all 510(k) submissions?
Yes, as of October 1, 2023, all 510(k) submissions must be submitted using the electronic Submission Template And Resource (eSTAR) PDF. The FDA no longer accepts older formats. Our platform is built around the eSTAR structure to ensure full compliance with all 19 sections.
What are the most commonly missed requirements?
The most commonly missed requirements include cybersecurity documentation for software devices, packaging integrity validation for sterile devices, interoperability testing for connected devices, and requirements traceability matrices for complex devices. Our comprehensive checklist ensures you don't miss any critical requirements.