SaMD 510k Process

Achieving FDA 510(k) clearance for Software as a Medical Device (SaMD) requires a clear, structured approach that demonstrates your software’s safety, performance, and substantial equivalence to a legally marketed device. This page outlines our comprehensive SaMD 510k process including regulatory strategy, risk classification, software documentation, cybersecurity validation, and submission preparation, ensuring manufacturers understand each step from initial planning to FDA clearance. With our proven expertise in SaMD regulatory pathways, we help developers navigate complex FDA expectations and achieve a smooth, efficient approval journey.

FDA 510k for Software as a Medical Device

Obtaining FDA 510(k) clearance for Software as a Medical Device (SaMD) can be a demanding and highly detailed process. Successfully navigating this pathway calls for precise documentation, strong technical justification, and a clear understanding of FDA expectations.

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Software as a Medical Device 510k Process

Phase 1 – Initial Details
Document Requirements		Scope of I3CGlobal	Scope of 510(k) Applicant
1.1	Intended use	Identification of product code	Provide an appropriate intended use of the Software device.
1.2	Indication s of Use Statement (Form 3881)	Filling of form based on details provided by the 510(k) applicant. Guiding the applicant if required in providing the appropriate Indications for use statement based on intended use and product code	Provide appropriate indications for use of the Software device in compliance to intended use. Provide Device Name. Confirm the type of Device i.e., Prescription Use or Over the Counter Use.
1.3	software medical Device Description	Review of device description details shared by applicant. Preparation of Device Description template as per FDA premarket submission Guidance.	Provide the basic details of software as a medical device which include features of software. Summary of the functions of the software medical device Software description Software architecture diagram.
1.4	Predicate Device	Provide the list of potential predicate devices. Selection of predicate device by confirmation from applicant.	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 Software as a Medical Device like indications of use, the material of construction, any claims etc.
1.6	Software	Documentation Level Evaluation. Share the queries related to level of concern documentation required.	Confirmation of Level of Concern Documentation.

Phase 2 – Software Supporting Documentation based on Level of Concern
Document Requirements		Scope of I3CGlobal	Scope of 510(k) Applicant
2.1	Proposed SaMD Labelling	Review the User Manual shared by the applicant. Create a template.	Provide User Manual. Provide promotional Material.
2.2	Software Device Description	Provide the list of elements to be include in the device description. Prepare the description based on device description details provided by the applicant.	Provide the device description details of Device Feature controlled by software, Analysis of Data and Inputs and Outputs.
2.3	System and Software Architecture	Provide sample deployment of software architecture. Provide the details to be descripted for documentation. Review the document provided by the applicant.	Provide the software architecture diagram with details regarding – the modules and layers that make up the system and software – the relationships among the modules and layers – the data inputs/outputs and flow of data among the modules and layers – how users or external products, including IT infrastructure and peripherals interact with the system and software.
2.4	Software Requirement Specifications	Provide the details to be descripted for documentation. Review the document provided by the applicant.	Minor Level of concern: Summary of functional requirements from SRS. Moderate and Major: Provide the SRS documents the requirements for the software: detailing the below elements. – inputs and outputs – functions that the software will perform – hardware – programming language – compiler version – performance – interfaces – user interaction -error definition and handling – response times -intended operating environment – safety related requirements derived from a risk assessment.
2.5	Software Design Specifications	Provide the list of sections to be descripted for documentation. Review the document provided by the applicant.	Minor Level of Concern: No documentation is required. Moderate and Major Level of Concern: Provide a singular SDS document or set of SDS documents can be used. Details to be included are: – technical design details of how the software functions, how the software design completely and correctly implements all the requirements of the SRS and how the software design traces to the SRS in terms of intended use, functionality, safety, and effectiveness. – software functional units or modules along with the interfaces among them identified in the architectural (i.e., high level) design should be documented with the corresponding detailed (i.e., low-level) design information in the SDS.
2.6	Software Development and Maintenance Practices	Provide guidance in documentation. Review of documents.	Minor Level of Concern: No documentation is required. Major and Moderate level of Concern: Provide a Declaration of Conformity to IEC 62304. OR Moderate level of concern: Provide a summary of the life cycle development plan and a summary of configuration management and maintenance activities. Major Level of concern: All the details of moderate level of concern and Annotated list of control documents generated during development process.
2.7	Software testing as part of verification and validation	Review of documents concern to software testing.	Minor Level of Concern: System level test plan, including pass/fail criteria and results. Moderate Level of concern: Provide a summary description of the testing activities at the unit, integration, and system levels. System level test protocol including expected results, observed results, pass/fail determination, and system level test report. Major Level of concern: Complete details as per moderate level of concern and Test protocol, plan and results of unit and integration of software.
2.8	Risk Management File	Provide template of Risk management plan and risk management report covering the all the device related risks. Review of the documents.	Provide a Risk management plan, risk assessment demonstrating that risks have been appropriately mitigated and risk management report. Provide the documentation covering cyber security elements like threat modelling, hazard analysis, trace matrix, mitigation measures etc. If possible, should be provide with separate sections for clear understanding.
2.9	Revision History	Review of the documents.	Provide the Revision history tabulating the major changes to the software during the development cycle, including date, version number, a brief description of the changes relative to the previous version, and indication of the version on which testing was performed.
2.10	Unresolved Anomalies	Review of the documents.	Minor Level of Concern: No Documentation is necessary. Moderate and Major Level of Concern: Provide the List of remaining software anomalies (e.g., bugs, defects) annotated with an explanation of the impact on safety or effectiveness, including operator usage and human factors, workarounds, and timeframe for correction.
2.11	Hardware Requirements	Review of the documents.	Provide all the hardware involved in the functioning of software device.
2.12	Software Compliance Documents and Certificates	Provide the guidance about required elements to be documented in concern to software compliance documents based on the device details provided by applicant. Provide the information relates to certification concern to software device based on device details shared by the applicant.	Provide all the compliance documents applicable to the software device.

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	510(k) Cover Letter	Prepare a template which includes details to list in the cover letter.	The document printed on company letterhead must be signed and hard copy couriered to the US office. 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	Declarations of conformity and Summary report	Create a template listing and prepare the document.	The document signed by the contact person at the firm should be provided.
4.4	MDFUSC (FDA Form 3601)	Create 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

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