Regulatory In A Box : FDA & EU MDR Compliance Made Simple for Digital Health Builders

510(k) in a box

510(k) Submission-ready framework for Software as a Medical Device (SaMD)

FDA 510(k) in a Box provides a complete set of FDA 510(k) submission document templates designed to help digital health teams prepare a compliant submission for software-based medical devices.

All documents are provided in editable Word and PDF format and are structured as fill-in-the-blank templates with embedded questions and guidance notes explaining what FDA expects and how to tailor each section to your specific product.

fda 510(k) in a box image

What’s Included

510(k) Administrative & Regulatory Documents

  • FDA 510(k) Cover Letter
  • FDA Form 3514 – CDRH Premarket Review Submission Cover Sheet
  • Indications for Use Statement (FDA Form 3881)
  • Truthful and Accuracy Statement
  • 510(k) Summary template (or 510(k) Statement option)
  • Device classification and regulatory pathway rationale

Device & Software Description

  • Device Description template
  • Software Description and Intended Use template
  • System architecture and software overview
  • Operating environment and interface description
  • Intended user and use environment description

Predicate Comparison & Substantial Equivalence

  • Predicate Device Comparison Table
  • Substantial Equivalence Rationale template
  • Technological characteristics comparison
  • Performance and functionality comparison

Software Documentation (510(k) Submission Level)

  • Software Level of Concern determination template
  • Software Development Summary (IEC 62304–aligned)
  • Software Hazard Analysis (submission-level)
  • Software Requirements Summary
  • Software Architecture Summary
  • Revision Level History
  • Unresolved Anomalies List

Software Verification & Validation

  • Software Verification Plan
  • Software Verification Report
  • Software Validation Plan
  • Software Validation Report
  • Requirements–Risk–Test Traceability Matrix

(Aligned with IEC 62304 expectations at FDA submission level)

510(k) Risk Management

  • Risk Management Plan
  • Hazard Identification and Risk Analysis
  • Risk Control Measures
  • Residual Risk Evaluation
  • Risk Management Report

(Aligned with ISO 14971 and FDA expectations)

Usability & Human Factors (as applicable)

  • Intended User Profile
  • Use-Related Risk Analysis (URRA)
  • Usability Engineering Summary
  • Human Factors Validation Summary

(Aligned with IEC 62366 where applicable)

Cybersecurity Documentation

  • Cybersecurity Risk Assessment
  • Threat Identification and Risk Analysis
  • Secure Design and Risk Control Measures
  • Software Bill of Materials (SBOM)
  • Cybersecurity Labeling Statements

(Aligned with FDA 510(k) cybersecurity guidance)

Performance & Supporting Evidence

  • Software Performance Testing Summary
  • Bench Testing Summary
  • Clinical Evidence Rationale (if applicable)
  • Literature Review Summary

Format & Guidance

  • Editable Word and PDF documents
  • Fill-in-the-blank structure for all templates
  • Embedded guidance explaining:
    • What FDA expects
    • Why each section is required
    • How to adapt content to your device

Standards & Frameworks

FDA 510(k), IEC 62304 (submission-level), ISO 14971, IEC 62366, FDA cybersecurity guidance

Who This Is For

  • Digital health and SaMD teams preparing an FDA 510(k)
  • Startups without in-house regulatory expertise
  • Teams looking for structured, practical submission documentation

Scope Clarification

This package provides submission-level documentation templates to support FDA 510(k) preparation.
It does not replace a full ISO 13485 Quality Management System or a complete IEC 62304 software lifecycle system.

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Request access to FDA 510(k) in a Box to receive structured, guided documentation templates for your submission.

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