FDA 510k Change Guidance.
Encoded into Intelligent Decision Trees.
Our system encodes FDA 510k change guidance into intelligent decision trees. Determine if your device change requires a new 510k, letter to file, or special 510k using FDA 510k change guidance.
AI-powered change impact assessment. Instant regulatory pathway determination. $200 per assessment.
Draft Letter to File is Included when applicable.
FDA 510k change guidance provides the framework for determining regulatory pathways when modifying cleared devices. When you modify a 510k-cleared medical device, determining the regulatory pathway can be complex. Does your 510k modification require a new 510k, a letter to file, or qualify for a special 510k? Our intelligent system encodes FDA 510k change guidance into decision trees to provide accurate, consistent assessments for all types of device changes. Also known as a Regulatory Change Assessment, No-Filing Justification, or 510(k) Decision Record, our service provides comprehensive documentation—and when a letter to file is recommended, we include a complete draft letter to file ready for your use.
How Our Intelligent System Works
Behind every assessment is a sophisticated decision tree system that encodes FDA guidance documents, ensuring accurate and consistent regulatory pathway determinations.
Encoded FDA 510k Change Guidance Decision Trees
Our system doesn't just reference FDA 510k change guidance—it encodes it into structured decision trees. For 510k software changes, 510k design changes, 510k material changes, 510k labeling changes, and 510k manufacturing changes, we've built separate decision trees based on FDA 510k change guidance that mirror FDA's regulatory logic.
Intelligent Change Type Detection
The system automatically detects whether your change affects labeling, design, software, or multiple areas. It evaluates change in intended use 510k scenarios, change in indications for use 510k cases, sterilization change 510k modifications, and technology change 510k updates.
Comprehensive Change Impact Assessment
Every assessment performs a complete 510k change impact assessment, evaluating significant effect safety effectiveness, analyzing device modification risk, and considering the cumulative effect of changes 510k when multiple modifications have been made.
Regulatory Pathway Determination
Using the 510k decision tree logic, the system determines whether your change requires a new 510k, qualifies for a letter to file, or can proceed via special 510k pathway. The assessment considers substantial equivalence change implications and provides clear regulatory recommendations.
Detailed Change Analysis Report
Receive a comprehensive 510k change analysis report that explains the regulatory pathway determination, cites relevant FDA guidance, and provides audit-ready documentation for your quality system records. When a letter to file is recommended, the service also includes a draft letter to file (also known as a Regulatory Change Assessment, No-Filing Justification, or 510(k) Decision Record) ready for your use.
Device-Specific Regulatory Context
The system retrieves your device's regulatory context—product code, regulation number, device class—and applies device-specific guidance to ensure the most accurate assessment possible.
FDA 510k Change Guidance: The Intelligence Behind the System
What makes our 510k modification assessment system truly intelligent isn't just AI—it's the systematic encoding of FDA 510k change guidance into structured decision trees that can be consistently applied across thousands of device change scenarios.
FDA 510k change guidance provides the official framework for determining regulatory pathways. When FDA publishes FDA 510k change guidance on when is a new 510k needed, that guidance contains specific criteria, decision points, and regulatory logic. Our system doesn't just read this FDA 510k change guidance—it encodes it into executable decision trees that mirror FDA's regulatory reasoning.
Three Specialized Decision Trees
- Labeling Change Decision Tree: Evaluates changes to intended use, indications for use, warnings, contraindications, and labeling clarifications. Determines if a 510k labeling change requires a new 510k, letter to file, or can be documented in change records.
- Design Change Decision Tree: Assesses 510k design changes, 510k material changes, performance modifications, and patient contact material changes. Evaluates whether design modifications significantly affect safety or effectiveness.
- Software Change Decision Tree: Analyzes 510k software changes, architecture modifications, function changes, and cybersecurity implications. Determines regulatory pathway for software modifications using FDA's software change guidance.
How Decision Trees Encode FDA Guidance
FDA guidance documents contain conditional logic: "If the change affects X and Y is true, then Z pathway applies." Our decision trees capture this logic precisely. For example:
- Significant Change Criteria: The system evaluates whether a change creates a significant effect safety effectiveness by checking multiple factors: new technology introduction, risk profile changes, intended use modifications, and performance specification alterations.
- Cumulative Effect Analysis: When multiple changes have been made, the system performs cumulative effect of changes 510k analysis, evaluating whether the combination of changes collectively requires regulatory action even if individual changes might not.
- Substantial Equivalence Evaluation: For changes that might affect substantial equivalence, the system performs substantial equivalence change analysis to determine if the modified device remains substantially equivalent to the predicate.
Device-Specific Regulatory Intelligence
Beyond generic guidance, our system retrieves device-specific regulatory context. When you provide a K number, the system:
- Retrieves your device's product code, regulation number, and device class
- Applies device-specific guidance from RegulationCard database
- Considers device category-specific requirements (e.g., software as a medical device, combination products, IVDs)
- Evaluates changes in context of your device's specific regulatory classification
Why FDA 510k Change Guidance Matters
Traditional 510k change impact assessment relies on manual interpretation of FDA 510k change guidance, which can lead to inconsistent determinations. Our encoded decision trees based on FDA 510k change guidance ensure that every assessment follows the same logical framework, reducing subjectivity and improving accuracy.
Whether you're evaluating a 510k software change, 510k design change, 510k material change, 510k labeling change, 510k manufacturing change, change in intended use 510k, change in indications for use 510k, sterilization change 510k, or technology change 510k, the system applies the same rigorous, FDA 510k change guidance-encoded logic consistently.
Assess All Types of 510k Device Changes
Our system evaluates every type of device modification using encoded FDA guidance decision trees.
510k Software Change
Evaluate software modifications, architecture changes, function updates, and cybersecurity implications. Determine if your 510k software change requires a new 510k, letter to file, or special 510k.
510k Design Change
Assess design modifications, geometry changes, and structural alterations. Our decision tree evaluates whether your 510k design change significantly affects safety or effectiveness.
510k Material Change
Evaluate material substitutions, patient contact material changes, and biocompatibility implications. Determine regulatory pathway for 510k material change modifications.
510k Labeling Change
Assess labeling modifications, intended use changes, indications for use updates, and warning additions. Evaluate whether your 510k labeling change requires regulatory action.
510k Manufacturing Change
Evaluate manufacturing process modifications, facility changes, and process control updates. Determine if your 510k manufacturing change affects device safety or effectiveness.
Change in Intended Use
Assess modifications to device intended use or target population. Evaluate whether change in intended use 510k or change in indications for use 510k requires a new 510k submission.
Sterilization Change
Evaluate sterilization method modifications, validation changes, and sterility assurance updates. Determine regulatory pathway for sterilization change 510k modifications.
Technology Change
Assess technology modifications, algorithm updates, and scientific technology changes. Evaluate whether your technology change 510k introduces new questions of safety or effectiveness.
The Decision-Making Process
Understanding when is a new 510k needed requires evaluating multiple factors. Our 510k change impact assessment system performs comprehensive analysis using encoded FDA guidance.
Key Evaluation Criteria
- Significant Effect on Safety or Effectiveness: The system evaluates whether your change creates a significant effect safety effectiveness by analyzing risk profile modifications, performance specification changes, and safety feature alterations.
- Device Modification Risk Analysis: Every assessment includes device modification risk analysis, evaluating whether the change introduces new risks, increases existing risks, or affects risk mitigation strategies.
- Cumulative Effect Assessment: When multiple changes have been made, the system performs cumulative effect of changes 510k analysis to determine if the combination of changes collectively requires regulatory action.
- Substantial Equivalence Evaluation: The system evaluates whether your change affects substantial equivalence change by comparing the modified device to the original cleared device and predicate.
- 510k Decision Tree Logic: Using our encoded 510k decision tree, the system follows FDA's regulatory logic to determine the appropriate pathway: new 510k, letter to file, special 510k, or documentation in change records.
Letter to File vs New 510k: FDA 510k Change Guidance
One of the most common questions is: letter to file vs new 510k—which pathway applies? Our system evaluates your specific change against FDA 510k change guidance criteria:
- New 510k Required: When the change significantly affects safety or effectiveness, introduces new technology, changes intended use, or creates new questions of safety or effectiveness.
- Letter to File: When the change doesn't significantly affect safety or effectiveness but should be documented for FDA awareness and quality system records. When our assessment recommends a letter to file, the service includes a complete draft letter to file (also called a Regulatory Change Assessment, No-Filing Justification, or 510(k) Decision Record) that documents your decision and is ready for use in your quality system.
- Special 510k: When the change doesn't affect intended use, fundamental scientific technology, or raise new safety/effectiveness questions, but requires abbreviated submission.
Comprehensive 510k Change Analysis
Every assessment includes a detailed 510k change analysis that:
- Documents the change description and rationale
- Evaluates regulatory impact using encoded FDA guidance
- Determines the appropriate regulatory pathway
- Provides audit-ready documentation for quality system records
- Cites relevant FDA guidance documents and regulations
Regulatory Pathway Determination
Our system uses FDA 510k change guidance encoded into decision trees to determine the appropriate regulatory pathway for your device modification. The assessment evaluates your specific change and provides clear recommendations on whether you need a new 510k, letter to file, or special 510k submission.
Understanding Regulatory Pathways
When you modify a 510k-cleared device, FDA 510k change guidance provides three primary regulatory pathways:
- New 510k Submission: Required when your change significantly affects safety or effectiveness, introduces new technology, changes intended use, or creates new questions of safety or effectiveness. Our system evaluates all factors using FDA 510k change guidance decision trees to determine if a new 510k is required.
- Letter to File: Appropriate when the change doesn't significantly affect safety or effectiveness but should be documented for FDA awareness and quality system records. The system determines if your change qualifies for letter to file based on FDA 510k change guidance criteria. When a letter to file is recommended, our service includes a complete draft letter to file (also referred to as a Regulatory Change Assessment, No-Filing Justification, or 510(k) Decision Record) that you can use directly in your quality system records.
- Special 510k: Available when the change doesn't affect intended use, fundamental scientific technology, or raise new safety/effectiveness questions, but requires abbreviated submission. Our assessment evaluates whether your modification qualifies for the special 510k pathway.
How Our System Determines Regulatory Pathway
The regulatory pathway determination process follows FDA 510k change guidance encoded into our decision trees:
- Change Type Analysis: The system first identifies the type of change (software, design, material, labeling, manufacturing, sterilization, or technology) and routes it to the appropriate decision tree based on FDA 510k change guidance.
- Risk Assessment: Evaluates whether the change introduces new risks, increases existing risks, or affects risk mitigation strategies. This device modification risk analysis is critical for regulatory pathway determination.
- Substantial Equivalence Evaluation: Determines if the change affects substantial equivalence by comparing the modified device to the original cleared device and predicate. Changes affecting substantial equivalence typically require a new 510k.
- Decision Tree Logic: Using our encoded 510k decision tree based on FDA 510k change guidance, the system follows FDA's regulatory logic step-by-step to determine the appropriate regulatory pathway.
- Clear Recommendations: The assessment provides clear, actionable recommendations on the regulatory pathway, with supporting rationale based on FDA 510k change guidance.
Why Regulatory Pathway Matters
Choosing the correct regulatory pathway is critical for compliance and efficiency. An incorrect pathway determination can lead to:
- Delays in bringing your modified device to market
- FDA requests for additional information or resubmission
- Compliance issues during FDA inspections
- Unnecessary regulatory burden and costs
Our system ensures accurate regulatory pathway determination by encoding FDA 510k change guidance into intelligent decision trees that consistently apply FDA's regulatory logic to your specific device change.
Change Impact Assessment
A comprehensive 510k change impact assessment evaluates all aspects of your device modification to determine its regulatory implications. Our system performs thorough change impact assessment using FDA 510k change guidance to analyze safety, effectiveness, and regulatory requirements.
What is Change Impact Assessment?
A 510k change impact assessment is a systematic evaluation of how a device modification affects:
- Safety and Effectiveness: The assessment evaluates whether your change creates a significant effect safety effectiveness by analyzing risk profile modifications, performance specification changes, and safety feature alterations.
- Regulatory Classification: Determines if the change affects the device's regulatory classification, product code, or device class, which impacts the regulatory pathway.
- Substantial Equivalence: Evaluates whether the modification affects substantial equivalence to the original cleared device and predicate, a key factor in determining if a new 510k is required.
- Quality System Requirements: Assesses documentation needs, verification/validation requirements, and quality system record-keeping obligations.
Components of Our Change Impact Assessment
Our 510k change impact assessment includes comprehensive analysis of:
- Device Modification Risk Analysis: Every assessment includes thorough device modification risk analysis, evaluating whether the change introduces new risks, increases existing risks, or affects risk mitigation strategies. This analysis follows FDA 510k change guidance on risk evaluation.
- Cumulative Effect Analysis: When multiple changes have been made, the system performs cumulative effect of changes 510k analysis to determine if the combination of changes collectively requires regulatory action, even if individual changes might not. This is critical for devices with ongoing modifications.
- Change Type Impact: Evaluates the specific impact of your change type (software, design, material, labeling, manufacturing, sterilization, or technology) using specialized decision trees based on FDA 510k change guidance.
- 510k Change Analysis: Provides detailed 510k change analysis that documents the change description, rationale, regulatory impact evaluation, and pathway determination with supporting FDA guidance citations.
- Decision Tree Evaluation: Uses our encoded 510k decision tree logic to systematically evaluate your change against FDA 510k change guidance criteria, ensuring comprehensive and consistent assessment.
Why Change Impact Assessment is Critical
A thorough 510k change impact assessment is essential because:
- Regulatory Compliance: Ensures you follow the correct regulatory pathway based on FDA 510k change guidance, avoiding compliance issues and FDA requests for additional information.
- Risk Management: Identifies potential safety or effectiveness concerns early, allowing you to address them before submission or market release.
- Documentation: Provides audit-ready documentation for your quality system records, demonstrating due diligence in regulatory decision-making.
- Efficiency: Helps avoid unnecessary regulatory submissions when changes qualify for letter to file or can be documented in change records, saving time and resources.
- Consistency: Our encoded decision trees ensure consistent change impact assessment across all device modifications, reducing subjectivity and improving accuracy.
Our system performs comprehensive 510k change impact assessment using FDA 510k change guidance encoded into intelligent decision trees, providing you with accurate, consistent, and audit-ready assessments for all types of device modifications.
What's Included in a Letter to File (Regulatory Change Assessment)
When our assessment determines that a letter to file (also called a Regulatory Change Assessment, No-Filing Justification, or 510(k) Decision Record) is the appropriate regulatory pathway, our service includes a complete draft letter to file ready for your use. This comprehensive document follows FDA guidance and industry best practices to ensure your quality system records are audit-ready.
Essential Components of a Letter to File
According to FDA guidance and industry standards, a letter to file should comprehensively document the rationale for determining that a device modification does not require a new 510(k) submission. Our draft letter to file includes all essential components:
- Description of the Modification: A clear, detailed description of the specific changes made to the device, including design modifications, material changes, manufacturing process updates, labeling alterations, or changes to intended use. The letter documents exactly what changed and how it affects the device.
- Risk Analysis and Assessment: A thorough risk assessment evaluating potential impacts of the modification on device performance, patient safety, and effectiveness. The letter includes analysis of whether the change introduces new risks, increases existing risks, or affects risk mitigation strategies.
- Regulatory Assessment and Justification: A comprehensive regulatory assessment that references relevant FDA guidance documents (such as "Deciding When to Submit a 510(k) for a Change to an Existing Device") and regulations to support the decision that the modification does not necessitate a new 510(k) submission. The letter explains why the change does not significantly affect safety or effectiveness.
- Supporting Data and Documentation: References to relevant test data, validation reports, scientific literature, or other evidence that substantiates the assessment. The letter documents any verification or validation activities performed to support the conclusion.
- Decision Rationale: A clear explanation of the decision-making process, including evaluation against FDA 510k change guidance criteria, assessment of substantial equivalence, and analysis of cumulative effects if multiple changes were made.
- Conclusion and Summary: A summary of findings that affirms the modification does not significantly affect the device's safety or effectiveness, and therefore, a new 510(k) is not required. The conclusion is supported by the analysis and references FDA guidance.
Why Letter to File Documentation Matters
While a letter to file is an internal document, it should be prepared with the same level of detail and rigor as a 510(k) submission because:
- FDA Inspection Readiness: FDA inspectors may review letters to file during facility inspections to verify that manufacturers are properly evaluating device modifications and making appropriate regulatory decisions.
- Quality System Compliance: Letters to file demonstrate compliance with Quality System regulation (21 CFR 820) requirements for documenting design changes and regulatory decisions.
- Regulatory Due Diligence: Comprehensive documentation shows that the manufacturer has thoroughly evaluated the modification and made an informed decision based on FDA guidance.
- Audit Trail: Letters to file provide a clear audit trail for regulatory decision-making, which is essential for quality system records and regulatory compliance.
Our Draft Letter to File Service
When our assessment recommends a letter to file pathway, we provide a complete draft letter to file that includes all essential components. Our draft letter:
- Documents your specific device modification in detail
- Includes comprehensive risk analysis based on your change
- References relevant FDA guidance documents and regulations
- Provides regulatory justification supported by FDA 510k change guidance
- Includes sections for supporting data and documentation
- Presents a clear conclusion with regulatory rationale
- Is formatted for easy integration into your quality system records
The draft letter to file is ready for your review and can be customized with your company information, signatures, and any additional supporting documentation. This saves you significant time and ensures your documentation meets FDA expectations and industry best practices.
Frequently Asked Questions
Common questions about FDA 510k change guidance and device modification assessments.
FDA 510k change guidance refers to FDA's official guidance documents that explain when device modifications require regulatory action. The FDA has issued two key guidance documents:
- "Deciding When to Submit a 510(k) for a Change to an Existing Device" - Provides a framework for assessing various types of device modifications, including changes to design, labeling, materials, and technology.
- "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" - Focuses on software modifications, offering a risk-based approach to evaluate whether a new 510(k) is required.
Our system encodes this FDA 510k change guidance into intelligent decision trees that automatically evaluate your device change and determine if a new 510k, letter to file, or special 510k is required.
According to FDA 510k change guidance (21 CFR 807.81(a)(3)), a new 510k is required when a device modification:
- Significantly affects safety or effectiveness
- Introduces new technology
- Changes intended use or indications for use
- Creates a new or increased risk
- Alters the fundamental scientific technology of the device
Our AI-powered assessment tool uses FDA 510k change guidance encoded into decision trees to evaluate your specific change and determine the regulatory pathway.
Letter to File: An internal documentation method used when a device modification is deemed not to significantly impact safety or effectiveness. This approach is appropriate for minor changes that don't alter the device's intended use or fundamental scientific technology. Examples include minor labeling updates or component changes that don't affect performance. The change is documented in your quality system records. When our assessment recommends a letter to file, the service includes a complete draft letter to file (also known as a Regulatory Change Assessment, No-Filing Justification, or 510(k) Decision Record) ready for your use.
New 510k: Required when the modification could significantly affect the device's safety or effectiveness. This includes changes that introduce new technology, change intended use, or create new questions of safety or effectiveness.
Our system evaluates your specific change using FDA 510k change guidance decision trees to determine which pathway applies.
A letter to file (also called a Regulatory Change Assessment, No-Filing Justification, or 510(k) Decision Record) should comprehensively document the rationale for determining that a device modification does not require a new 510(k) submission. According to FDA guidance and industry best practices, a letter to file should include:
- Description of the Modification: A clear, detailed description of the specific changes made to the device, including design modifications, material changes, manufacturing process updates, labeling alterations, or changes to intended use.
- Risk Analysis and Assessment: A thorough risk assessment evaluating potential impacts of the modification on device performance, patient safety, and effectiveness. This should analyze whether the change introduces new risks, increases existing risks, or affects risk mitigation strategies.
- Regulatory Assessment and Justification: A comprehensive regulatory assessment that references relevant FDA guidance documents (such as "Deciding When to Submit a 510(k) for a Change to an Existing Device") and regulations to support the decision that the modification does not necessitate a new 510(k) submission.
- Supporting Data and Documentation: References to relevant test data, validation reports, scientific literature, or other evidence that substantiates the assessment. This includes any verification or validation activities performed to support the conclusion.
- Decision Rationale: A clear explanation of the decision-making process, including evaluation against FDA 510k change guidance criteria, assessment of substantial equivalence, and analysis of cumulative effects if multiple changes were made.
- Conclusion and Summary: A summary of findings that affirms the modification does not significantly affect the device's safety or effectiveness, and therefore, a new 510(k) is not required.
While a letter to file is an internal document, it should be prepared with the same level of detail and rigor as a 510(k) submission, as it may be subject to FDA inspection. When our assessment recommends a letter to file, our service includes a complete draft letter to file with all these essential components, ready for your review and customization.
A Special 510k is an abbreviated submission pathway for manufacturers making changes to their own legally marketed devices. According to FDA 510k change guidance, a Special 510k is appropriate when:
- The modification does not alter the device's intended use
- The fundamental scientific technology remains unchanged
- Well-established methods are available to evaluate the change
- All necessary performance data can be reviewed in a summary or risk analysis format
Special 510ks leverage the manufacturer's design control procedures to support the substantial equivalence determination, potentially reducing review times. Our assessment tool determines if your change qualifies for a special 510k pathway based on FDA 510k change guidance.
FDA 510k change guidance for software modifications uses a risk-based approach. Our system uses encoded FDA guidance decision trees specifically for software changes. It evaluates:
- Whether the software change affects device function
- If the change introduces new risks
- Whether the software architecture has changed
- If the change affects cybersecurity
- The cumulative effect of multiple software changes
The assessment considers the cumulative effect of changes and determines if a new 510k, letter to file, or special 510k is required based on FDA 510k change guidance.
A 510k change impact assessment evaluates whether a device modification requires regulatory action. Our AI-powered tool performs comprehensive change impact assessments by:
- Analyzing the modification against FDA 510k change guidance decision trees
- Considering factors like safety, effectiveness, intended use
- Evaluating technology changes
- Assessing cumulative effects of multiple changes
- Determining the appropriate regulatory pathway
The assessment provides audit-ready documentation that cites relevant FDA 510k change guidance documents and regulations.
The FDA has issued two key guidance documents for 510k modifications:
- "Deciding When to Submit a 510(k) for a Change to an Existing Device" - Provides a framework for assessing various types of device modifications, including changes to design, labeling, materials, and technology. This guidance emphasizes risk-based assessment and provides illustrative examples and flowcharts.
- "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" - Focuses specifically on software modifications, offering a risk-based approach to evaluate whether a new 510(k) is required for changes in software functionality, architecture, or performance.
Our system encodes both of these FDA 510k change guidance documents into intelligent decision trees that automatically evaluate your device modification.
A letter to file is appropriate when a device modification does not significantly affect safety or effectiveness. According to FDA 510k change guidance, this includes:
- Minor changes that don't alter the device's intended use
- Changes that don't affect fundamental scientific technology
- Minor labeling updates that don't change indications or warnings
- Component changes that don't affect performance
It's essential to maintain thorough records of these assessments, as they may be reviewed during FDA inspections. Our assessment tool evaluates your change against FDA 510k change guidance to determine if a letter to file is appropriate.
The cumulative effect of changes refers to evaluating multiple modifications together, even if individual changes might not require regulatory action. FDA 510k change guidance requires manufacturers to consider whether the combination of changes collectively affects safety or effectiveness.
For example, several minor changes that individually don't require a new 510k might collectively require regulatory action if their combined effect significantly impacts the device. Our assessment tool performs cumulative effect analysis to determine if multiple changes together require a new 510k submission based on FDA 510k change guidance.
According to FDA 510k change guidance, a design change requires a new 510k if it:
- Significantly affects safety or effectiveness
- Changes patient contact materials in a way that affects biocompatibility
- Alters performance specifications that could impact device function
- Modifies geometry or structure in a way that affects device performance
- Changes the fundamental scientific technology
Our system uses encoded FDA 510k change guidance decision trees to evaluate design changes and determine the regulatory pathway.
All device modifications must be documented as required by the Quality System regulation (21 CFR 820). According to FDA 510k change guidance:
- All changes should be documented in your quality system records
- If a new 510k is required, the submission should fully describe all changes and their impacts
- Documentation should include the rationale for the regulatory pathway determination
- Records should be maintained for FDA inspection review
Our assessment tool generates comprehensive change impact reports that document the modification, regulatory pathway determination, and rationale based on FDA 510k change guidance, providing audit-ready documentation for your quality system records.
See Sample Reports
View real examples of our AI-powered 510k modification assessment reports. See how our system evaluates device changes and determines regulatory pathways using encoded FDA guidance.
510k Change Impact Assessment Report
This sample report demonstrates our comprehensive change impact assessment for device modification K141160. The report includes regulatory pathway determination, risk analysis, FDA guidance citations, and detailed recommendations based on encoded decision trees.
View Sample Report (PDF)Sample Letter to File / Device Change Note to File
This sample letter to file (also called a Device Change Note to File, Regulatory Change Assessment, No-Filing Justification, or 510(k) Decision Record) demonstrates the comprehensive draft letter to file included when our assessment recommends this pathway. The letter includes change description, risk analysis, regulatory assessment, and decision rationale for device modification K141160.
View Sample Letter to File (PDF)Start Your FDA 510k Change Guidance Assessment
Get an instant, AI-powered assessment of your device change using FDA 510k change guidance encoded into decision trees. Determine if you need a new 510k, letter to file, or special 510k submission based on FDA 510k change guidance.
Draft Letter to File is Included when applicable.