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IVD Device 510k

510k IVD Submission Workflow

This page outlines the end-to-end Phases of 510(k) IVD submission workflow in a clear, step-by-step format, showing key requirements and responsibilities across each phase. It is organized to help website viewers quickly understand what information and documents are needed, how the work progresses from initial device details through supporting documentation and administrative forms, and how tasks are divided between I3CGlobal and the 510(k) Applicant for efficient preparation and final e-STAR submission.

 

The structured layout is designed for easy reading and navigation, allowing stakeholders to track progress, identify dependencies, and align regulatory, quality, and technical teams at each stage of the submission. By presenting the workflow in well-defined phases and tables, this overview supports better planning, transparency, and compliance while reducing the risk of delays during FDA review.

Statement Of Work - Phases of 510(k) IVD

(Comprehensive Regulatory Submission Workflow)

510K IVD

Phase 1 – Initial Details
# Requirements Scope of I3CGlobal Scope of 510(k) Applicant
1.1 Intended use
  • Initiate intended use requisition for the IVD (Reagent/ system/Instrument).
  • Determination of product code and regulation number.
  • Share an appropriate intended use of the IVD (Reagent/ system/Instrument).
  • Finalization of product code.
1.2 Indications of Use Statement (Form 3881)
  • Initiate requisition for indications for use, including OTC use /Prescription use and Patient Population for IVD (Reagent/ system/Instrument).
  • Review the shared Indications for Use details and draft the Indications for Use statement aligned with the Intended Use and Product Code.
  • Document the Indications for use Form 3881.
  • Provide appropriate indications for the use of the IVD (Reagent/ system/Instrument) with Prescription Use /Over-the-counter use and Patient population.
  • Finalization of Indications for use.
1.3 Device Description
  • Initiate a device description information request that addresses the following: Technical characteristics of the device, Principle of operation, Photographs of the device and its components.
Reagent: (Standalone/Kit)
  • Requisite, review, and document: Test type (Quantitative/Qualitative), Assay analytical principle, Reagent formulation /composition, Specimen data, Active components, Kit configuration (if applicable) in detail, including all components and consumables.
  • Components/accessories, Compatibility analyzer platforms(if applicable).
IVD Instrument and Systems:
  • Requisite, review, and document: Functions, and modalities, Overall system configuration, System components, Software functionality, System connectivity and interoperability, Electronic architecture (the power supply, voltage, and current type, control unit/PCB, sensors or transducers, user interface (displays/indicators), and alarm systems (visual and/or audible), as applicable, Connectivity features, embedded interface.
  • Share the recommended details, which include: Overview of the device, Material and Composition of the device, Mode of action/Principle of action, Photographs of the device and components.
Reagent: (Standalone/Kit)
  • Provide the following details: Test type (Quantitative/Qualitative) with intended analytical use.
  • Assay principle (e.g., immunoassay, enzymatic, chemical reaction, molecular hybridization), reagent reaction with the analyte, Measurable result after reaction.
  • Active components (e.g., antibodies, antigens, enzymes, primers, probes) in reagent composition.
  • Specimen type.
  • Kit Configuration: List of components included, Number of vials/bottles, Volume per component, Presence of controls or calibrators, etc.
  • Compatibility of reagent with any intended analyzer platforms, with rationale and requirements.
IVD Instrument and Systems:
  • Provide the following: System functions and modalities (if software), System configuration (System components and connectivity, modules, subunits, etc.), Data and control flow, Electronic architecture in detail with output.
  • Integrated detection module, and a user interface, operated by embedded software (if software).
1.4 Predicate Device
  • Select and share the potential predicate device based on the product code and device description.
  • Confirmation of a suitable predicate device.
1.5 510(K) Summary
  • Prepare a template.
  • Write up the comparative table between the subject and predicate device.
  • Summary and add discussion on the comparison table.
  • Approval of the final write-up.
Phase 2 – IVD Supporting Documentation based on Indications for Use
# Document Requirements Scope of I3CGlobal Scope of 510(k) Applicant
2.1 Device Drawing
  • Initiate, review, and document a requisition for a Device Drawing and design of development for IVD (Reagent/ system/Instrument).
Reagent:(Standalone/Kit)
  • Visual image of the reagent and the container.
  • Complete kit and its components.
Instrument and system:
  • Drawings of all system components showing system configuration and interaction.
  • External instrument image/drawing (front/side/top as applicable) explaining instrument layout and function.
  • Provide device drawing/Image of the device.
Reagent:(Standalone/Kit)
  • Pictorial, visual, or image of device and its accessories.
Instrument and system:
  • System configuration diagram (how components connect) with a system-level block diagram.
  • External instrument image/drawing (front/side/top as applicable) with High-level internal block diagram identifying: Power supply, Control unit / PCB, Sensors/detectors, User interface, Ports/connectors.
2.2 Material safety data Sheet
  • Send a requisition for a Material Safety Data Sheet of crucial components of the IVD (Reagent/ system/Instrument).
  • Review and document for 510(k) submission.
  • Provide Material safety data sheet of crucial components of IVD(Reagent/ system/Instrument).
2.3 Manufacturing Flowchart
  • Initiate review and document for the Manufacturing Flow chart of the IVD (Reagent/ system/Instrument).
  • Provide a detailed Manufacturing Flow chart of the IVD (Reagent/ system/Instrument).
2.4 Proposed Labelling
  • Initiate a requisition for Primary, Secondary, and Tertiary labels, IFU, User Manual/ E-manual, promotional material, and website documents, and on receipt, review and document for 510k submission.
  • Provide the latest updated revisions of all documents for IVD (Reagent/ system/Instrument).
2.5 Sterilization (if applicable.)
  • Initiate requisition for sterilization validation study plan and reports.
  • Review and document the study plan and reports.
  • Provide sterilization study plan and reports.
2.6 Shelf life
  • (Applicable for IVD Reagents and kits).
  • Initiate, review, and document shelf-life study plan and report, recommending storage conditions, including humidity, temperature, and light conditions.
  • Provide a shelf-life study plan and report that should contain details and evidence supporting the claimed shelf-life.
2.7 Packaging & Transportation
  • Send a requisition for the Packaging and transportation Validation study plan and reports.
  • Review and document the packaging and transportation validation study plans and report.
  • Provide packaging and transportation validation study plans and reports.
2.8 Biocompatibility
  • (Biological evaluation of materials that directly or indirectly contact patient specimens or patients, as applicable.)
  • Determine the endpoints of biocompatibility.
  • Initiate requisition for Biocompatibility test plan and reports, and review and document.
  • Provide biocompatibility test plan and reports.
2.9 EMC and Electrical safety
  • (IVD Instruments and Systems (Embedded firmware devices).
  • Initiate a requisition for EMC and an electrical safety study plan and Reports.
  • Identify the applicable FDA consensus standards.
  • Guidance in alignment of study plan/protocol and report as per FDA guidance criteria, considering IVD system/Instrument Configuration and Function.
  • Prepare and document a summary for EMC and electrical safety.
  • Provide the electrical device characteristics and intended use environments including: Device overview, functions and operating modes.
  • Block diagrams, photographs, cables, relevant accessories, and interoperability.
  • A description of the power supply (mains-powered, internally powered, or both, including use while charging).
  • The intended use environments and any wireless technology.
  • Identification and consideration of common and device-specific electromagnetic (EM) and internal RF emitters.
  • A detailed device description covering configuration, functions, operating modes, user-selectable settings and tested configurations, device name, model number, and manufacturer.
  • Confirm that the tested device represents the final, production-ready commercial configuration.
  • Risk assessment related to electrical safety.
2.10 Software
  • (IVD Systems and Instruments (Embedded software).
  • Send a requisition for software documentation as per FDA guidance and FDA-recognized standards.
  • Determine the documentation level.
  • Review and document for 510k submission.
  • Provide a detailed document for the software applicable, including: Confirmation of documentation level (Basic/Enhanced).
  • Brief software description.
  • Risk management file.
  • Software interoperability.
  • Software architecture.
  • Software requirement specifications.
  • Software design specifications.
  • Software Development, Configuration Management, and Maintenance Practices.
  • Revision history.
  • Verification and validation.
  • Cybersecurity (if applicable).
  • Unresolved anomalies.
  • Software compliance documents.
2.11 Performance Testing _ Bench
  • Send a requisition for Analytical performance studies plans and reports of the IVD types Reagents/Instruments/ Systems.
  • Provide instructions to include a detailed description of the study design, including sample population, sample size, and tests recommended.
  • Provide a clear outline of the analytical methods and procedures used to evaluate the performance of the IVD device.
  • Verify whether the validated methods and instruments with Conduct studies are in accordance with relevant standards (e.g., CLSI, ISO).
  • Verify and share review comments on the study conducted in accordance with the protocol and whether reflecting the same in reports.
  • Verify the data results in the report are accurate, complete, and reliable.
  • Writeup the conclusions from the supported data results supported by the data and are reasonable and well-supported.
  • Ensure proper documentation and traceability throughout the submission process.
  • Verify approval from relevant stakeholders (e.g., QA, regulatory affairs).
  • Ensure that the summary and conclusions are appropriate and supported by the data in the test ports shared.
  • Verify approval from relevant stakeholders (e.g., QA, regulatory affairs).
  • Prepare the performance testing bench template and compile the document with results.
  • Prepare performance summary report template and share the template for approval.
  • Document for 510k submission.
  • Provide Analytical performance studies plans and reports.
  • The document should include: Declaration form that selected lab is approved for conducting IVD study as per USFDA requirements.
  • A description of the selection and the method of the studies performed.
  • Summary of the evidence related to the test measurement procedure.
  • Summary of the level of validation required for performance characteristics (e.g. comparison validation, analytical validation).
  • Summary of the analytical result and conclusion drawn from the studies.
  • A list or referenced standards or guidelines used for assessing the studies.
2.11 Risk Assessment
  • Send a requisition for Risk Management File, including: Risk plan, Risk hazard assessment, Risk Report.
  • Provide a template of the Risk management plan and report covering all the device-related risks (on request from the applicant).
  • Review the Risk Management File data containing the Plan, assessment, and Report shared by the applicant and suggest the necessary corrections if required.
  • Document for 510(k) submission.
  • Share a Risk management plan, risk assessment demonstrating that risks have been appropriately mitigated, and a risk management report covering all risk elements.
  • Provide the suggested updated final risk documents.
2.12 Clinical Study (if applicable)
  • Send requisition for clinical study plan and report.
  • Initiate recommendations, including clinical evidence with literature to support the documentation.
  • Review the study plan and report and provide suggestions per FDA guidelines.
  • Prepare and compile a Clinical study summary report and send a template for approval.
  • Document for 510k submission.
  • Share a clinical validity study plan and report.
  • Provide Clinical evidence with literature.
  • Approve the final Clinical study Summary report for 510k submission.
Phase 3 – Initial Documents and Substantial Equivalence Documents
# Document Requirements Scope of I3CGlobal Scope of 510(k) Applicant
3.1 CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)
  • Fill out the FDA Form 3514 based on the details provided by the applicant.
  • -
3.2 Class III Summary and Certification
  • Not necessary if clinical studies are not required.
  • -
3.3 Financial Certification or Disclosure Statement
  • Not necessary if clinical studies are not required.
  • -
3.4 Executive summary
  • Create a template and prepare the document.
  • Justify any differences between the proposed device and the predicate device.
  • Comparative study between the proposed device and the predicate device chosen.
3.5 Substantial Equivalence Discussion
  • Create a template and prepare the document.
  • A comparative study between the proposed device and the predicate device is chosen.
Phase 4 – Administrative Documents
# Requirement Scope of I3CGlobal Scope of 510(k) Applicant
4.1 510(k) Cover Letter
  • Prepare a ready-to-use cover letter template with all required details as FDA requirement.
  • Provide a Soft copy of signed 510(k) cover letter for 510(k)documentation.
4.2 Truthful and Accuracy Statement
  • Provide a template with the required content to be mentioned and document for submission.
  • The document signed by the contact person at the firm should be provided.
4.3 MDFUSC (FDA Form 3601)
  • Send a requisition to share the MDFUSC.
  • Document for 510k submission.
  • Make payment to the USFDA.
  • (Before submission of 510(k) file.)
4.4 Letter of Authorization
  • Create a template and include the authorized person responsible for the submission process.
  • Provide the authorization by signature and date of the person responsible for the Submission and interaction process.
Phase 5 – RTA Checklist and E-STAR Submission
# Requirement Scope of I3CGlobal Scope of 510(k) Applicant
5.1 Q-Submission (Optional – Recommended before testing)
  • Prepare FDA-appropriate questions about the device.
  • Organize the submission sections as required for a Pre-Submission.
  • Upload documents and complete the FDA Pre-Submission template using the latest version.
  • Submit the Q-Submission through the FDA CDRH Portal.
  • Track FDA review progress and communicate with the FDA reviewer during the review process.
  • Review and confirm the questions prepared.
  • Share device details and relevant test plans to support the Q-Submission.
Phase 6 – E-STAR Submission (Final 510k Submission)
# Requirement Scope of I3CGlobal Scope of 510(k) Applicant
6.1 E-STAR Preparation
  • Update documents based on FDA feedback.
  • Finalize all 510(k) documents and forms.
  • Organize the final submission folder.
  • Complete and check the e-STAR submission template to ensure all required sections are included.
  • Review the updated documents.
  • Share updated inputs such as test reports, labeling, and risk documents.
  • Approve the final submission package before it is prepared in e-STAR format.
6.2 E-STAR Submission
  • Submit the completed e-STAR package through the FDA CDRH Portal.
  • Confirm successful submission and share FDA confirmation with the client.
  • Provide additional information if FDA requests clarification (e.g., payment or administrative issues that may cause an RTA notice).