Software Medical Device

Software medical device refers to standalone software intended for medical purposes only, and not integrated with another device of primary use. SaMD is made usually to manage patient data, aid in decision making or support clinical decision-making. These software applications can range from simple mobile health apps to complex algorithms for diagnosing diseases or managing treatment plans.

Software medical device is subject to regulatory oversight by FDA in the United States, MHRA in the United Kingdom or the European Commission (EC) in the European Union. Depending on the risk classification and intended use, SaMD requires regulatory clearance or certificates before it can be marketed and used in clinical practice.

FDA 510k for Software Medical Device

Securing FDA 510k clearance or premarket notification for a software medical device is a complex and stressful undertaking. The 510(k) process is a submission made to the FDA to demonstrate that a medical device is substantially equivalent to a device that is already legally marketed for the same use.

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Types of Software as a Medical Device

Software as a Medical Device (SaMD) encompasses a wide range of software applications used in healthcare for diagnostic, therapeutic, or monitoring purposes. These software devices vary in complexity and function. Here are some common types of software devices:

Clinical Information System (CIS)
Electronic Prescription (EP) System
Clinical Decision Support Systems (CDSS)
Radiology Information Systems (RIS)
Laboratory Information System (LIS)

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Software Medical Device FDA compliance and Consultant role

The role of a 510(k) SaMD consultant is to guide software developers through the complete process streamline the 510(k) submission process, and ultimately help get 510k clearance faster.

Software medical device FDA consultants help assess whether the software medical device in question is substantially equivalent to the predicate device. This involves technical debate with the developer team by comparing the intended use, technological characteristics, state-of-the-art, and performance data of the new device to those of the predicate device.
SaMD Consultants assist in preparing the 510(k) documentation file as per abbreviated or traditional way, which includes writeup on device description, indications for use, labelling, software documentation, risk analysis, software version controls, software testing and performance testing data. They ensure that the submission is comprehensive and meets FDA requirements.
510(k) consultants provide recommendations for remediation to address identified gaps and ensure that the device meets applicable standards.
Consultants help software developers establish a robust risk management process for the software medical device, including identifying potential hazards (limited to general knowledge of consultants), assessing risks, implementing risk controls, and documenting risk management activities.
SaMD Consultants facilitate communication between the software medical device developer and the FDA throughout the 510(k)-review process if required. Consultants / US Agents interact with the FDA on behalf of the developer, respond to inquiries or requests for additional information, and update the 510k file.

Overall, the role of a software 510(k) consultant is essential for small and medium-sized developers to guide the regulatory maze, streamline the 510(k)-submission process, and ultimately help bring safe and effective software medical devices to market in compliance with FDA regulations

Software Medical Device 510k Process

Phase 1 – Initial Details
Document Requirements		Scope of I3CGlobal	Scope of 510(k) Applicant
1.	Intended use	Identification of product code	Provide an appropriate intended use of the Software device.
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.
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.
4.	Predicate Device	Provide the list of potential predicate devices. Selection of predicate device by confirmation from applicant.	Approval of a suitable predicate device.
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 SaMD like indications of use, the material of construction, any claims etc.
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 – 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 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 predicate device. Comparative study between the proposed device and predicate device chose.
3.5	Substantial Equivalence Discussion	Create a template and prepare the document. Comparative study between the proposed device and predicate device chose.

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 – RTA Checklist and E-Copy
Document Requirements		Scope of I3CGlobal	Scope of 510(k) Applicant
5.1	RTA Checklist	Create an RTA Checklist Template based on type of submission. Fill the checklist and ensure that mentioned documents to be submitted to the FDA.	Approval of Verification of RTA Checklist.
5.2	E-Copy	Arrangement of submission folder sections as per FDA Guidance. Convert to e-copy. E-copy submission to US Agent	Approval of Final submission Folder documentation.

Indeed, 510(k) consultants are pivotal in helping software as a medical device developers meet the regulatory requirements necessary for introducing their software products to market, thereby ensuring both regulatory compliance and patient safety.

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Frequently Asked Questions

What are the key components of a 510(k) submission for a software medical device?

The key components in a SaMD 510k file are the following

Device description, including software architecture and functionality.
Risk analysis and mitigation strategies.
Software verification and validation testing results.
Substantial equivalence comparison to a predicate device.
Labeling and user instructions.

What is substantial equivalence, and how do I demonstrate it?

Substantial equivalence means that the new SaMD has the same intended use and technological characteristics as that of a predicate device or if any differences in terms of architecture, software functionality, and performance that do not raise new questions about safety and effectiveness.

What is required in the SaMD documentation for a 510(k)?

Software documentation typically includes:

Software Description
Software Requirements Specification (SRS)
Architecture Design Chart
Software Development Environment Description
Verification and Validation Documents
Risk Management File
Traceability Matrix (linking requirements, risks, and test results)

How should I handle software modifications in a 510(k) submission?

Any modifications to the software after the initial 510(k) clearance must be carefully assessed to determine if a new 510(k) application is required. This is done by checking any changes on the device intended use, performance, functionality and safety. If the changes are significant, a new 510(k) application is necessary.

What is the common issues SaMD 510(k) rejection?

Common reasons of 510k application rejections are the following:

Inadequate risk management documentation.
Insufficient software validation and verification testing.
Failure to clearly demonstrate substantial equivalence.
Poorly organized submission documents.
Missing or incomplete cybersecurity considerations.

What is the role of cybersecurity in a software medical device 510(k) submission?

Cybersecurity is critical for ensuring the safety and effectiveness of software as a medical devices (SaMD). The FDA requires documentation of cybersecurity measures, including threat modeling, risk assessment, and mitigation strategies. Software developers must demonstrate that the software is designed to protect against unauthorized access, data breaches, and other security threats.

Does I3CGLOBAL request a pre-submission SaMD?

Indeed, the I3CGlobal team prepares and submits pre-submission documents and questions to the FDA to receive feedback on your submission strategy. This can be especially beneficial for addressing particular concerns or questions. However, the downside is a project delay of 2-3 months.

What is expected timeline for a SAMD 510k clearance?

The timeline depends on the following factors

How good and effectively developer implemented IEC 62304.
Complicity of the device
Coordination with consultants if any and the technical team involved in the project
Pre-submission necessities
Software (SAMD) version changes in case