FDA 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 with shared responsibilities
(Comprehensive Regulatory Submission Workflow)
| 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 suggest 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 (power supply, voltage, current type, control unit/PCB, sensors or transducers, user interface, alarm systems), Connectivity features, Embedded interface. |
Share the recommended details, which include: Overview of the device, Material and Composition, Mode of action/Principle of action, Photographs of the device and components. Reagent (Standalone/Kit): 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), Specimen type, Kit Configuration details, Compatibility of reagent with intended analyzer platforms. IVD Instrument and Systems: System functions and modalities, System configuration (components and connectivity, modules, subunits), Data and control flow, Electronic architecture in detail with output, Integrated detection module and user interface operated by embedded 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 | CLIA Complexity Assessment and Regulatory Strategy | Assess whether the device may qualify for CLIA Waiver based on intended use, workflow, user interaction, and result interpretation. Evaluate the most appropriate regulatory pathway (510(k) only or Dual 510(k) + CLIA Waiver). Identify potential CLIA-specific study requirements, if applicable. Provide regulatory recommendations and discuss them during Q-Submission (if applicable). |
Provide details of intended users, testing environment, workflow, sample preparation, and result interpretation. Share available data, if available. Confirm whether the CLIA Waiver is a commercial objective. Review and approve the proposed regulatory strategy. |
| 1.6 | 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 a device drawing/image of the device. Reagent (Standalone/Kit): Pictorial, visual, or image of the 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; 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 electrical safety study plan and reports. Identify the applicable FDA consensus standards. Provide 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; Description of the power supply (mains-powered, internally powered, or both, including use while charging); Intended use environments and any wireless technology; Identification and consideration of common and device-specific electromagnetic (EM) and internal RF emitters; Detailed device description covering configuration, functions, operating modes, user-selectable settings and tested configurations, device name, model number, and manufacturer; Confirmation 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 detailed documentation 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 of 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 are conducted in accordance with relevant standards (e.g., CLSI, ISO). Verify and share review comments on whether the study was conducted in accordance with the protocol and reflecting the same in reports. Verify the data results in the report are accurate, complete, and reliable. Write up the conclusions from the supported data results, ensuring they are reasonable and well-supported. Ensure proper documentation and traceability throughout the submission process. Verify approval from relevant stakeholders (e.g., QA, regulatory affairs). Prepare the performance testing bench template and compile the document with results. Prepare a performance summary report template and share for approval. Document for 510k submission. |
Provide Analytical performance studies plans and reports. The document should include: Declaration form that the 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 of 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 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 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. |
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| Phase 4 – Administrative Documents | |||
| Document Requirements | 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 per FDA requirement. | Provide a soft copy of the 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 the 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 | |||
| Document Requirements | 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) | |||
| Document Requirements | 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). |
| 6.3 | eCopy Preparation and Validation (If Applicable) |
Prepare the FDA-compliant eCopy package for submissions requiring eCopy format. Perform eCopy verification and validation in accordance with FDA requirements. Verify file structure, hyperlinks, and submission integrity. Support submission of the validated eCopy package via CDRH portal, if applicable. Confirm successful submission and share FDA acknowledgement with the client. Track FDA review progress and support responses to Additional Information (AI) requests, if any. |
Provide any additional documentation required for submission. Review and retain FDA acknowledgement records. |
| Phase 7 – CLIA Submission | |||
| Document Requirements | Scope of I3CGlobal | Scope of 510(k) Applicant | |
| 7.1 | Dual Submission (510k and CLIA Waiver) |
Prepare CLIA waiver documentation as part of the Dual 510(k) and CLIA Waiver submission. Prepare CLIA-specific device description and regulatory justification, as applicable. Review risk management documentation and identify CLIA-related considerations. Identify and review CLIA-specific study requirements, including waived user, reproducibility, flex, and interpretation studies, as applicable. Organize and compile the final submission package. Complete and review the eSTAR submission to ensure all required sections are included. Submit the Dual 510(k) and CLIA Waiver package through the FDA CDRH Portal. Support review of FDA questions and Additional Information (AI) requests, if any. |
Review and approve submission documents. Provide final study reports, labeling, risk management documentation, and supporting evidence. Review and approve the final submission package. Provide responses and supporting information requested during FDA review. |
| 7.2 | CLIA Waiver Standalone Submission (Moderate and high complexity category after 510k Clearance) |
Assess CLIA categorization and waiver strategy following FDA clearance. Identify additional studies and documentation required to support a CLIA Waiver by Application. Review CLIA-related study reports and supporting documentation. Prepare and compile the CLIA Waiver submission e-package folder. Conduct final quality review of the e-copy submission folder and submit e-copy to FDA. Support FDA review activities and responses to Additional Information (AI) requests, if any. Submit the Additional Information (AI) requests via e-copy. Receive CLIA status from the FDA and share the CLIA waiver status with the client. |
Provide required CLIA study reports and supporting documentation. Review and approve CLIA-specific submission documents. Provide required signatures and authorizations. Review and approve the final submission package. Provide additional information requested by the FDA during review. |
* The information provided above table is believed to be accurate based on our experience at the time of publication. However, Errors and Omissions Excepted (E&OE). Updated by Amrutha Rai on April 2026