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.

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.