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.