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A Guide On FDA Software As A Medical Device

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    Posted in Healthcare Software

    Last Updated | November 30, 2022


    Technology has become an integral part of the healthcare industry, without which healthcare services’ efficiency and high standard maintenance would be compromised. Medical device app development and software have also shaped the way providers, and patients interact, how patients manage their health, and even how doctors practice medicine. 

    Various software operates at the core of the industry, assisting providers with both medical and nonmedical practices such as financing, accounts, and much more! But with the use of software come compliance issues that facilities need to focus on.

    The {Top} digital health organizations prioritize software validation for two reasons: either to maintain compliance or raise standards of quality to ensure essential software is running the way it should. But the procedure for FDA software validation is quite tricky. This is because, even though FDA requires companies to get it done, a process has not been specified. 

    FDA has published recommendations. However, although they are lengthy, the regulations are complicated. Plus, their guidelines do not cater to every healthcare provider in the healthcare sector. 

    What is FDA Software?

    Software is not only intended to aid healthcare facilities and make the lives of providers easier, but it also aims to meet user needs and provide them with functions according to their requirements.

    Plus, while installing software, a company must ensure that it is installed correctly and does not compromise the safety of its users. The process of software validation sums all of this up, but documented evidence is required for this. 

    This evidence must confirm whether the software has been installed correctly and will meet user needs without adversely affecting efficiency. Contrary to popular belief, even healthcare apps require FDA approval.

    But what is FDA software validation?

    The FDA has set out certain guidelines for quality management and compliance procedures like choosing a HIPAA-compliant telehealth software etc.  FDA software validation refers to the demonstration and documentation by an FDA-regulated company to prove that their software can produce accurate and consistent results. These companies must also meet the predetermined guidelines set by FDA. 

    Although the FDA provides recommendations, it does not state how companies must validate their software or what the results should be similar to.  In other words, each company decides on its own how it will validate its software and provide proof of validation in an intended way. In most cases, the companies purchase software from third-party vendors. Despite this, the company is responsible for validating the software, not the third-party vendor.  

    Medical Device FDA Definition

    Software has influenced the healthcare industry to a great extent. 

    One technological advancement in digital health tech that has revolutionized the industry is the development of software designed to perform complex medical functions.  This is referred to as software as a medical device (SaMD).  SaMD is equipped to diagnose medical conditions and even suggest treatment plans. It can also send alerts to the clinical management team regarding treatments, diagnoses, and other medical information. 

    SaMD refers to software intended to perform one or several medical functions. Consequently, it can be used across several tech platforms related to the healthcare industry. 

    For instance, Software as a medical device is commonly used on medical device platforms, virtual networks, etc.  One important thing that must be noted is that SaMD is not the software that facilitates the functionality of the hardware. 

    This means software that animates an X-ray control panel is not considered software as a medical device. Neither is it the software that fetches data, optimizes processes, or organizes information. Often, the software is embedded into a piece of hardware. However, it is the software that performs the medical function. 

    Some of the features of SaMD are listed below:

    • Through personalized patient information, it can determine an accurate drug dose for patients.
    • It can use MRI images to diagnose a stroke.
    • Deduce the risk of melanoma by tracking mole size over time. 
    • Identifies risk factors of epileptic seizures by retrieving data from several digital devices.

    Software as a Medical Device Market Size

    Technology has benefitted the healthcare industry for several years. It has raised the standards of services provided by practitioners thanks to Hl7 integration. 

    (What is hl7 integration? It ensures healthcare data is synced with EMRs with maximum protection while enhancing communication within a healthcare organization.) SaMD, intended to diagnose, treat, and prevent diseases, is mainly used with nonmedical computing platforms typically linked with either virtual networks or general-use hardware.

    Since the healthcare sector is anticipated to increase the adoption of connected devices and digital healthcare solutions, the SaMD market will experience growth in the period predicted by market analysts. 

    Another factor that will plummet the growth of the SaMD market is the ease of regulations surrounding the certification of software as a medical device.  During the forecast period, it is predicted that investments in SaMD will increase, which means market players and stakeholders are guaranteed to flourish further during this period. 

    One major factor that has impacted the growth in the SaMD market is the launch of the Internet of Things (IoT).  Today, several digital platforms have been converted to medical devices, thanks to IoT. 

    Consequently, more devices have been developed that have benefitted all levels of treatment. This includes not only in-patient treatment but also population health control monitoring.  The current pandemic situation has acted as a catalyst to boost the growth of the market for SaMD. 

    Since patients were advised to avoid visiting hospitals and the severe shortages of hospital beds, this boosted the growth of the SaMD market.  

    FDA Guidance on Software as a Medical Device

    FDA has come up with some healthcare compliance solutions to make all software classified as software as a medical device more universal.  It is essential for software as a medical device to support clinical language to be used. This rule targets the interface, which must include a linguistic design and appropriate instructions.

    The FDA also requires software as a medical device to address clinical evaluation methods. Plus, clinical evidence must be provided which matches the type of SaMD software.  Products that relate to a Medical device should not only be labeled with potential adverse effects but should also have recommendations attached for analytical reasons. 

    FDA Regulatory Requirements for Medical Devices

    As stated before, to gain the approval of the FDA, the company must present them with evidence showing that the device is not just safe to use but also effective. The FDA uses several tools to monitor the efficacy of marketed devices. 

    The most commonly used is MedWatch which is the FDA Safety Information and Adverse Event Reporting Program.  Via this program, both manufacturers and healthcare professionals can bring serious problems related to drug use to the attention of the FDA. 

    Although FDA is a dominant body in the healthcare sector in the US, it does not have the permission to:

    • Make medical recommendations, whether it is to clinics or individual doctors
    • Dictate providers on how their businesses should be run, or regulate the practice of an individual physician or a nurse. 
    • Conduct ratings on medical devices. 

    FDA Software as a Medical Device Classification

    Software as a medical device can be classified into the following 5 types: 

    Patient Data SaMD:

    This category includes several SaMD. Patient data SaMD collects patient information in real-time, which can then be monitored by medical professionals. 

    Vital statistics such as heart rate and blood pressure levels are collected by the SaMD, based on which clinicians develop treatment plans.  There are two benefits of this type of SaMD: it allows the doctor to monitor patients remotely and alter treatment plans based on their vitals in real time.

     Image Data SaMD:

    Medical practitioners use SaMD to interpret information that they have collected. The software is designed to create 3D models using the data gathered from radiation-emitting medical devices. 

    It then analyzes the models and uses the results, and comes up with a treatment plan. SaMD also collects more information if required. This depends on the treatment plan.

    Treatment Data SaMD:

    SaMD is used as an algorithm to analyze patient information.  The result produced is the foundation of the treatment plan for the patient. The algorithm requires patient data, including weight, blood pressure, heart rate, and age, to produce effective results. 

    It may also gather additional information if needed with the aim of helping the practitioner. 

    Sleep Data SaMD:

    While a patient is asleep, the software gathers physiological signals. This type of SaMD, when paired with a smartphone, can gather crucial information such as snoring measurements, sleep stages, arousals, and the quality of sleep. 

    This helps with the diagnosis of sleep-related disorders. 

    Breast Screening SaMD:

    This type of SaMD is used to identify potential risk factors associated with breast cancer. Breast tissue composition is measured through mammograms. This is paired with digital image analysis, which helps analyze a patient’s risk for breast cancer. 

    The software also provides information regarding whether further screening is required or a treatment plan needs to be developed. 

    FDA Software as a Medical Device Clinical Evaluation:

    There was a time when medical decisions were based on the judgment of clinicians themselves. But with the introduction of software as a medical device, times have changed. Now, these decisions that determine medical outcomes or patient care requirements are based on the data collected by software as a medical device.

    The Software as a Medical Device: Clinical Evaluation, which is the final guidance issued by FDA, states the principles that have been unanimously agreed upon. 

    This evaluation sets software’s safety and performance standards as a medical device that manufacturers can use to evaluate their SaMD.

    FDA Software as a Medical Device Quality

    Various medical issues can be addressed using FDA software as a medical device. Two of the best qualities of FDA software as a medical device are enhanced outcomes thanks to more accurate information and faster production of treatment plans. 

    SaMD allows practitioners to gather large amounts of data, including patient vitals.  In addition to the data gathering, software as a medical device can propose diagnoses to doctors. 

    This helps them come up with highly accurate treatment plans and treat the patients accordingly. Software as a Medical Device is usually utilized in the following phases of treatment:

    • Monitoring and alerting
    • Diagnosis
    • Screening
    • Management of chronic disease
    • Digital therapeutics

    How to Get FDA Approval for Software as a Medical Device?

    To seek the approval of the FDA, the software system must meet the specific requirements set by the FDA. The company must provide evidence that it has been installed correctly, meets the requirements, and features quality attributes. 

    Plus, the FDA also requires the software to fulfill the functions it has been designed for. The company must also validate the process that they plan to use to produce the medical device. 

    The company must not just focus on proving that the software fulfills its intended use, but also identify and find solutions to issues that could affect the production process negatively.  

    Informing FDA of a Change to a Medical Device

    FDA needs to stay informed of any changes that are made to a medical device. There are three methods of doing so.  Voluntary reporting to the FDA can be done easily via MedWatch, the FDA Safety Information, and Adverse Event Reporting Program.

    The company can report to the FDA through the online reporting portal. Any change in the medical device can also be done through the FDA Form 3500 for healthcare professionals. Another method is to submit the 3500B (Consumer/Patient) form directly to MedWatch. 

    But the question is, what else should be reported to MedWatch, other than any changes to a medical device:

    • Any problems with the product quality
    • Adverse effects that were never predicted initially
    • Therapeutic failures
    • Preventable product use errors

    FDA Software as a Medical Device Examples

    To understand how SaMD helps medical practitioners to gather data and make more accurate medical decisions, here are some examples of Software as a Medical Device:

    • Treatment planning software: is typically coupled with hardware medical devices to collect crucial vitals needed to develop treatment plans for patients.
    • Software connected with a medical device: Sometimes software is connected with a hardware medical device. 

    Since the hardware medical device does not require this software to achieve its intended goals, the software it is paired with cannot be considered an accessory to the medical device.

    • Software for Non-medical computing platforms: also utilize software as a medical device. These are likely to be located in the hardware medical device.

    US FDA Software as a Medical Device

    FDA plays a significant role in monitoring the safety of all medical products sold in the US.  It is responsible for the regulation of all medical device products in the country. This includes diagnostic tests and other medical device-related products.  

    If a company in the US intends to sell a medical device product legally, the FDA must approve it first before it makes its way to the medical market.

    The FDA has developed several regulations that are aimed to ensure maximum safety while using SaMD. 


    How much does FDA approval cost for a medical device?

    According to the FDA website, approvals for medical devices involve an establishment registration fee. This fixed fee cannot be waived or reduced in any case. Other fees vary according to the type of application. 

    Do you pay for FDA approval?

    The FDA is permitted to charge a user fee according to the specific applications by Federal Law. However, the fee can be reduced if the applicant is eligible for fee waivers or concessions. 

    Does FDA regulate software?

    According to section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), The FDA has monitored software that has been designed for treatments, prevention, diagnosis, or mitigation of any disease. 


    The cost of developing any software, for example, the cost of telemedicine softwareis high, but considering the profitability of the development of such apps, it is certainly worth considering. 

    But with software as a medical tool, there are several requirements that one has to meet and comply with numerous regulations, making it a complex procedure. 

    Despite that, the SaMD has benefitted the healthcare sector in several ways. From monitoring the patient’s vitals in real-time to coming up with effective treatment plans, it makes the growing reliance of medical practitioners on these tools quite understandable. Visit our website on Medical Device Software Development and get in touch with Folio3 Software experts.

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