FDA Software As a Medical Device

FDA Software As a Medical Device (FDA SaMD) is essential for marketing in U.S. The below page details few information about the approval process. Any software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device is known as software as a medical device (FDA SaMD).

It provide means and suggestions for mitigation of a disease, furnish formation for determining compatibility, detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities, avail to diagnosis, screening, monitoring, determination of predisposition, prognosis, prediction, determination of physiological status.

Software does not meet the definition of FDA SaMD under the following conditions:

If intended purpose is to drive a hardware medical device.
If relies on data from a medical device, but does not have a medical purpose.
If enables clinical communication and workflow including patient registration, scheduling visits, voice calling, and video calling.
If monitors performance or proper functioning of a device for the purpose of servicing the device, (e.g., software that monitors x-ray tube performance to anticipate the need for replacement), or software that integrates and analyzes laboratory quality control data to identify increased random errors or trends in calibration on IVDs.

A specific class of computer software used to provide low-level control for a specific hardware of a device is called firmware. The following are few examples of software medical devices.

⊗ Software functions that help patients having behavioral issues psychiatric conditions

⊗ Software helps de addition

⊗ Mobile apps that use GPS location information to alert environmental conditions that may cause asthma

⊗ Software functions that motivate patients to perform physical therapy at home

⊗ Software used in patient-specific screening, counseling

⊗ Software provide a list of possible medical conditions and advice patients

⊗ Software functions that enable a patient to create and send an alert.

⊗ Software functions that keep track of medications

⊗ Software helps patients a portal into their own health information

⊗ software features that compile and display patterns in occurrences involving one’s own health

⊗ Software features enable a user to gather blood pressure readings and distribute t/ track / upload it to a personal or electronic health record

⊗ Software features that give users with gum disease oral health reminders or tracking tools

⊗ Software features that give people with pre-diabetes advice or tools to assist them change their food habits or up their physical activity;

⊗ Software functions that generate reports with pertinent safety data

FDA SAMD Requirements:

Software may be used in combination (e.g., as a module) with other products including medical device without being part of” means software not necessary for a hardware medical device to achieve its intended medical purpose.
Software may be interfaced with other medical devices, including hardware medical devices and other FDA SaMD software, as well as general purpose software
Mobile apps that meet the parameters above are considered SaMD.

Software Levels of Concern

Level of concern is an estimation of the severity of the injury that a device can permit or inflict, either directly or indirectly, on a patient or operator. The injury may be a result of device failures, design flaws, or simply by virtue of employing the device for its intended use.

The different levels of concern are:

MAJOR

If a failure or latent flaw could directly result in death or serious injury to the patient or operator or

If a failure or latent flaw could indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of a care provider.

MODERATE

If a failure or latent design flaw could directly result in minor injury to the patient or operator or

If a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

MINOR

If failures or latent design flaws are unlikely to cause any injury to the patient or operator.

510(k) Documentation Requirements for each level of concern.

SOFTWARE DOCUMENTATION	MINOR CONCERN	MODERATE CONCERN	MAJOR CONCERN
Level of Concern	A statement indicating the Level of Concern and a description of the rationale for that level.
Software Description	A summary overview of the features and software operating environment.
Device Hazard Analysis	Tabular description of identified hardware and software hazards, including severity assessment and mitigations.
Software Requirements Specification (SRS)	Summary of functional requirements from SRS.	The complete SRS document.
Traceability Analysis	Traceability among requirements, specifications, identified hazards and mitigations, and Verification and Validation testing.
Software Development Environment Description	No documentation is necessary in the submission.	Summary of software life cycle development plan, including a summary of the configuration management and maintenance activities.	Summary of software life cycle development plan. Annotated list of control documents generated during development process. Include the configuration management and maintenance plan documents
Verification and Validation Documentation	Software functional test plan, pass / fail criteria, and results.	Description of V&V activities at the unit, integration, and system level. System level test protocol, including pass/fail criteria, and tests results.	Description of V&V activities at the unit, integration, and system level. Unit, integration and system level test protocols, including pass/fail criteria, test report, summary, and tests results.
Revision Level History	Revision history log, including release version number and date.
Unresolved Anomalies	No documentation is necessary in the submission.	List of remaining software anomalies, annotated with an explanation of the impact on safety or effectiveness, including operator usage and human factors.

How to determine level of concerns (LOC)?

Table 1: Major Level of Concern

If the answer to any one question below is Yes, the level of concern for the software device is likely to be Major.

Sl. No.	QUESTIONS	RESPONSE
1	Does the Software Device qualify as Blood Establishment Computer Software? (Blood Establishment Computer Software is defined as software products intended for use in the manufacture of blood and blood components or for the maintenance of data that blood establishment personnel use in making decisions regarding the suitability of donors and the release of blood or blood components for transfusion or further manufacture.)	Yes No
2	Is the Software Device intended to be used in combination with a drug or biologic?	Yes No
3	Is the Software Device an accessory to a medical device that has a Major Level of Concern?	Yes No
4	Prior to mitigation of hazards, could a failure of the Software Device result in death or serious injury, either to a patient or to a user of the device? Examples of this include the following:
a	Does the Software Device control a life supporting or life sustaining function?	Yes No
b	Does the Software Device control the delivery of potentially harmful energy that could result in death or serious injury, such as radiation treatment systems, defibrillators, and ablation generators?	Yes No
c	Does the Software Device control the delivery of treatment or therapy such that an error or malfunction could result in death or serious injury?	Yes No
d	Does the Software Device provide diagnostic information that directly drives a decision regarding treatment or therapy, such that if misapplied it could result in serious injury or death?	Yes No
e	Does the Software Device provide vital signs monitoring and alarms for potentially life threatening situations in which medical intervention is necessary?	Yes No

Table 2: Moderate Level of Concern

If the Software Device is not Major Level of Concern and the answer to any one question below is Yes, the level of concern is likely to be Moderate.

Sl. No.	QUESTIONS	RESPONSE
1	Is the Software Device an accessory to a medical device that has a Moderate Level of Concern?	Yes No
2	Prior to mitigation of hazards, could a failure of the Software Device result in Minor Injury, either to a patient or to a user of the device?	Yes No
3	Could a malfunction of, or a latent design flaw in, the Software Device lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury?	Yes No

If the answers to all of the questions in Tables 1 and 2 above are No, the Level of Concern is Minor.

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What is Device Hazard Analysis for all Software Devices?

Device Hazard Analysis document is to identify and assess both software and hardware hazards associated with the intended use of the medical device and should be included with premarket submission for all software devices. Risk analysis, evaluation, and control should be performed as per ISO 14971:2019 and documented.

The following information should be included:

Identification of each hazardous event
Cause and severity of hazards
Risk control methods
Any corrective actions taken
Verification of the risk controls

What do you mean by Unresolved Anomalies?

Any unsolved bugs existing in a software being released are known as unresolved anomalies. The risks associated with these anomalies and the impact on device performance should be evaluated and justification should be provided for the release. If applicable, timeline for fixing these bugs should also be mentioned.

What is Software Requirements Specifications (SRS) and Software Design Specifications (SDS)?

The Software Requirements Specification (SRS) describes the function of the software device and documents the requirements for the software like functional, performance, interface, design, developmental, and other requirements for the software.

The Software Design Specification (SDS) documents how the functions of the software device described in the SRS are implemented. The SDS is used to ensure that the work performed by the creators of the software devices was clear with minimal ad-hoc design decisions.

Detail requirements for Cyber security Labeling?

The cyber security labelling should contain description of the following

Device instructions and product specifications appropriate for the intended use environment.
Device features that protect critical functionality when cybersecurity is compromised.
Features to ensure backup and restore, and procedures to regain configurations.
Supporting infrastructure requirements for the device to operate as intended.
The device secure configurations is or how it can be hardened.
List of network ports and other interfaces.
Systematic procedures that can be used to download version-identifiable software and firmware from the manufacturer by authorized users.
Device design that can be used to announce when anomalous conditions are detected.
How forensic evidence is captured
Device configuration retention and recovery methods by an authenticated privileged user.
System diagrams in detail for end-users.
List of commercial, open source, and off-the-shelf software and hardware components to enable device users to effectively manage their assets, to understand the potential impact of identified vulnerabilities to the device, and to deploy countermeasures to maintain the device’s essential performance.
Technical instructions to permit secure network deployment and servicing, and instructions for users on how to respond upon detection of vulnerability or incident.
Information concerning device cybersecurity end of support.

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