510k submission for Active Device (With or Without a Software)

Obtaining FDA 510(k) for an active medical device, whether it includes embedded software or operates without it, requires a structured demonstration of safety, performance, and substantial equivalence to a legally marketed predicate. This page outlines the essential steps, documentation requirements, and regulatory considerations that manufacturers must follow to successfully navigate the 510(k) pathway for active devices.

Statement of Work (SOW)

Phase 1 – Initial Details
Requirements		Scope of I3CGlobal	Scope of 510(k) Applicant
1.1	Intended use	Send requisition for intended use statement Identify appropriate product code based on device characteristics Review and validate product code alignment	Provide clear, appropriate intended use of the active device Confirm product code accuracy and applicability Ensure alignment with device functionality
1.2	Indications of Use Statement (Form 3881)	Send requisition for indications for use Fill out Form 3881 based on 510(k) applicant details Assist in framing appropriate statements aligned with intended use and product code	Provide appropriate indications for use in compliance with intended use Provide complete device name Confirm device type: prescription use or over-the-counter use
1.3	Device Description	Send requisition for device description details through mail communication. Review all device description details shared by applicant for completeness and accuracy. Prepare and document Device Description template as per FDA premarket submission guidance requirements.	Provide the recommended details of the device which includes: overview of the device its functions and modes, block diagrams photographs, cables, and relevant accessories. device interoperability. a description of the power supply etc
1.4	Predicate Device	Identify and share the potential predicate device based on product code and device description.	Approval of a suitable predicate device.
1.5	510(K) Summary	Develop a template. Fill the manufacturer and device details. Fills the predicate device details	Provide details regarding the manufacturer- name, address, contact person at the company, contact number etc. Provide details of medical devices like indications of use, the material of construction, any claims, etc.

Phase 2 – Active Device Supporting Documentation based on Indications for Use
Document Requirements		Scope of I3CGlobal	Scope of 510(k) Applicant
2.1	Device Drawing	Send a requisition for a Device Drawing of an Active device and conduct final review before adding to 510k submission	Provide device drawing file from the design history file sec. 21 CFR 820.30(j)
2.2	Design and Development of the device	Send requisition for design development files. Review documentation and provide corrections if needed before moving to submission file	Provide complete device drawing files and comprehensive design and development documentation of the active device with SIMD as outlined in 21 CFR 820.30, Design Controls, which covers design planning, inputs, outputs, reviews, verification, validation, transfer, changes, and the Design History File.
2.3	Material safety data Sheet	Send a requisition for a Material safety data sheet of crucial components of the Active device. Review and document for submission.	Provide MSDS for all crucial components and detailed manufacturing flow chart of the active device.
2.4	Manufacturing Flow chart	Send a requisition for the Manufacturing Flow chart of the active device covering Software Architecture as per IEC 62304. Review and document for submission.	Provide a Manufacturing Flow chart of the hardware portion and software portion
2.5	Proposed Labeling	Send requisition for Primary, secondary and tertiary labels and on receipt review and document for 510(k) submission.	Provide later revisions of Labels
2.6	Proposed Device Information documents	Send requisition for IFU, User Manual, promotional materials and website documentation Review all labelling materials and document for 510(k) submission	Provide the latest approved versions of all documents including website url
2.7	Packaging & Transportation	Request packaging and transportation validation study plans and reports as per the latest standards identified. Review documentation and provide corrections if needed before moving to submission file	Provide device packaging details with drawings with the help of photographs (Primary pack and shipping pack) Provide complete transportation validation study plans and reports as per the latest standards.
2.8	Usability and Human Factors	Provides regulatory requirement level guidance & insights Reviews HFE outputs, prepares submission ready HFE summaries, and ensures proper integration into the Risk Management File and 510(k)	Develops and executes HFE deliverables, including the HFE plan, URRA, formative and summative studies, and final HFE report.
2.9	Performance Testing (Bench)	Send requisition for performance testing bench study plans and reports Review all testing documentation for completeness Document findings for 510(k) submission Ensure alignment with FDA requirements	Provide comprehensive performance testing bench study plans Submit complete testing reports with results Include all relevant data and analysis Demonstrate device performance meets specifications
2.10	Electrical Device Characteristics and Intended Use Environments	Identification and confirmation of applicable FDA-recognized consensus standards for EMC and electrical safety, with explanations for any deviations. Request and check incoming documentation of device functions, modes, block diagrams, power supply, wireless technology, RF emitters, and intended use environments. Request detailed description of medical device configuration and functions tested. Review and document for submission.	Provide Electrical Device characteristics and Intended Use Environments including: overview of the device, its functions and modes, block diagrams, photographs, cables, and relevant accessories and device interoperability. Adescription of the power supply (i.e., mains-powered only, internally powered only, mains and internally powered) including if the internally powered medical device can be used while charging. Tenvironments in which the medical device is intended to be used and description of any wireless technology (for additional considerations regarding wirelessly enabled medical devices. Description of any internal RF emitters in the medical device that could be sources of EM disturbances. Addressing common EM emitters and unique medical emitters Provide detailed description including configuration, functions, modes, settings tested, device name, model number, manufacturer, and confirmation of production-ready status.
2.11	Risk Assessment	Drafting Risk management documents based on the information provided inline with ISO 14971 Provides risk-related inputs (typically ~60% of the RMF content in official templates), reviews your risk analyses for regulatory alignment, supports integration of HFE outputs (URRA, formative, summative), and ensures risk-related content is accurately reflected in the 510(k), including Risk Management Summary	Implement and maintain the RMF, ensuring thorough hazard identification, mitigating risk, analysing hazards, verification of risk controls, and confirmation of RMF File.
2.12	Consensus Standard	Send requisition of consensus standards applicable for Active device EMC and electrical safety Document the confirmed Consensus standard for the active device for 510(k) submission.	Provide confirmation of applicable consensus standards and explanation of deviated standards from FDA-recognized standards.
2.13	Essential Performance and Immunity Pass/Fail Criteria	Send requisition for Essential Performance and Immunity tests study plan and reports as per FDA recognized standard for the active device. Review and document for 510(k) submission	Provide Essential Performance and Immunity tests study plan and reports as per FDA-recognized standards for active device
2.14	Medical Device Configuration and Functions Tested	Send requisition for Medical Device Configuration and Functions Tested of the active device. Review and document for 510(k) submission	Provide Medical Device Configuration and Functions Tested of the active device which includes: a detailed description of the medical device under test, including the configuration, functions, modes, and settings tested. description of the device under test should include the medical device name, model number, manufacturer, and an indication of whether the device is the final production-ready medical device currently under review.
2.15	Results of Safety Testing	Send requisition for safety testing plan and report as per FDA-recognized consensus standard recommended for active devices. Review and document for 510(k) submission	Provide study plan and report

Phase 3 – Substantial Equivalence and Executive Summary
Document Requirements		Scope of I3CGlobal	Scope of 510(k) Applicant
3.1	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 is chosen.	NIL
3.2	Substantial Equivalence Discussion	Create a template and prepare the document. Comparative study between the proposed device and the predicate device is chosen.	NIL

Phase 4 – Administrative Documents
Document Requirements		Scope of I3CGlobal	Scope of 510(k) Applicant
4.1	Letter of Authorization	Prepare and provide a copy to the applicant to provide authorization for communication with the USFDA for both Q-Submission and 510(k) submission.	Provide a soft copy of the signed letter of authorization on the company or organization letterhead.
4.2	510(k) Cover Letter & Q-Submission Cover letter	Prepare and provide a template to the applicant covering all details required for the cover letter and share with the applicant, instructing them to use the letterhead and provide the authorized person’s signature.	Provide a Soft copy of signed 510(k) cover letter for 510(k)documentation.
4.3	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.
4.4	MDFUSC (FDA Form (..))	Create a medical device user fee cover sheet and PIN.	Make payment to FDA. (Before submission of 510(k) file.)

Phase 5 – Pre STAR Submission (PreSubmission/Q-Submission)

Document Requirements

Scope of I3CGlobal

Scope of 510(k) Applicant

5.1

Q-Submission (optional) Recommended prior to testing

Frame the questions regarding the device as per FDA guidance.
Arrangement of submission folder sections as per Pre-star requirement guidance.
Upload the documents and fill in the recommended details, ensuring the latest version template via verification.
Submission via CDRH Portal.

Tracking of the review process and interacting with the US FDA reviewer throughout the review process.

Confirm the Questions framed. Share the test plans and device details

Phase 6 – eSTAR Submission (Final 510(k) Submission)

Document Requirements

Scope of I3CGlobal

Scope of 510(k) Applicant

6.1

eSTAR Preparation

Address and Incorporate FDA Pre-Submission feedback and recommendations into the package by updating the documents.
Update and finalize the full technical file (510(K) file) including substantial equivalence and administrative documentations
Arrangement of final submission folder

Populate and validate the eSTAR’s latest version template with all required sections, attachments and rationale (if any)

Review and revise the technical documents addressing the FDA feedback.
Provide with updated inputs (test reports, labeling, risk analysis, etc.) as required.

Confirm and approve the Final Submission folder prior to eSTAR packaging.

6.2

eSTAR Submission

Upload the completed and validated eSTAR package to the CDRH Portal.

Verify successful submission and share FDA acknowledgment

Provide any additional details if FDA issues RTA comments — RTA typically occurs due to user fee issues such as fee not received because of missing transaction charges or insufficient payment amount