First Opinion Corporation (La Jolla, CA)

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What is a software medical device?

The FDA can refer to the functions of software, which include ” Software As a Medical Device” and “Software in a Medical Device(SiMD)” which are software functions that are integral to (embedded within) a medical device.

Section 201(h),?21 U.S.C. 321(h)(1), defines an medical device as an instrument, apparatus, device or device, machine, implant or in vitro reagent or other similar or related device, including accessories or components that’s . . . (b) intended for use in the diagnosis of illnesses or other conditions or in the treatment, mitigation, treatment, or prevention of diseases in man or other animals, or (c) is designed to affect the structure or any functions of the body of man or other animals.? To be considered a medical device, and thus subject to FDA regulation, the software must meet at least one of the following conditions:

  • It is essential to use it in diagnosing and treating patients.
  • It should not be designed to alter the structure or function of the body.

If the software you use is designed to be utilized by healthcare professionals to diagnose treat or manage patient data in hospitals and other medical facilities, the FDA is likely to consider the software to be medical devices and subject to regulatory review.

Is Your Software a Medical Device?

According to FDA’s current approach to oversight, which considers the functionality of the software more than the device’s platform, FDA will apply its regulation only to medical devices with capabilities that could cause harm to the safety of patients. Some examples of Device Software and Mobile Medical Apps FDA is focused on

  • Software functions that aid patients suffering from diagnosed mental disorders (e.g., anxiety, depression, post-traumatic stress disorder (PTSD) and others.) by offering “Skill of the Day” or a behavioral strategy or audio-based messages that users can access when experiencing anxiety.
  • Software functions provide regular educational information, reminders, or motivational tips for smokers who are trying to quit, recovering from addiction, or pregnancies women;
  • Software functions that use GPS location information to alert asthmatics of conditions in the environment which could trigger asthma symptoms or notify an addiction patient (substance abusers) in proximity to a specified high-risk or high-risk location.
  • Software that uses video and games to encourage patients to take part in exercise at home.
  • Software functions that prompt a user to enter which drug and herb they would like to take concurrently and provide information about whether interactions have been observed in the literature and a summary of what type of interaction was reported;
  • Software functions that take into account patient characteristics, such as gender age, gender, and other risk factors, to provide patient-specific counseling, screening, and prevention recommendations from established and well-respected authorities.
  • Software functions that use an inventory of the most common signs and symptoms to provide the possibility of medical conditions , as well as advice on when it is appropriate to speak with the health professional;
  • Software functions help patients to complete a questionnaire regarding symptoms and make a recommendation on the best type of healthcare facility for their needs.
  • Mobile apps are intended to allow a user to make a pre-specified nurse or emergency call using broadband or mobile phone technology;
  • Apps that permit patients or their caregivers to send urgent notifications to first responders using mobile phones
  • Software functions that keep track of medicines and give users user-configured reminders for improved compliance with medication;
  • Software functions that give users access to their health data. This includes historical trends as well as comparisons of vital signs (e.g. body temperature, heart rate , blood pressure).
  • Software functions that aggregate and show trends in personal health events (e.g., hospitalization rates or alert notification rates);
  • Software functions allow users to gather (electronically or manually entered) blood pressure information and share this data through e-mail or track and analyze it, or even upload it into a personal or electronic health record.
  • Mobile apps that provide oral health reminders or tools to track users suffering from gum disease.
  • Apps that provide mobile access and aids for patients suffering from prediabetes;
  • Apps that allow users to display images and other messages on smartphones, which can be used by users of drugs who wish to stop their addiction.
  • Software functions that give drug interaction and safety information (side effects and drug interactions active ingredient active ingredient) in an analysis based on demographic data (age and gender) and current diagnosis (current medication) as well as clinical information (current treatment).
  • Software functions allow the surgeon to determine the most effective intraocular lens power for the patient as well as the orientation of the implant. The information is determined by the surgeon’s inputs (e.g. anticipated surgically induced astigmatism and patient’s axial length and preoperative corneal astigmatism , etc.).
  • Mobile apps, usually software which transforms mobile platforms into medical devices that are regulated.
  • Software that is connected to a mobile device using a sensor or a lead to measure and display the electrical signals generated by the heart (electrocardiograph, ECG).
  • Software that connects sensors or other devices to the mobile device so that it can monitor the eye’s movement to detect balance problems
  • Software that gathers data about potential donors and sends the information to an institution for blood collection. The software will determine the eligibility of a potential donor to collect blood or any other component.
  • Software that connects to an existing device for control of its operation, function, or power source.
  • Software that alters or disables the functions of an infusion pumps
  • Software that regulates the inflation and deflation a blood pressure cuff
  • Software that is used to calibrate hearing devices and evaluate the electroacoustic frequency, audio intensity characteristics, as well as sound quality of hearing aids master hearing aids hearing aids for groups, or auditory trainers for groups.

What does it mean if your software/SaaS is classified as a medical device?

SaaS founders need to be aware of the compliance risks that medical devices pose. Data breaches are one of the biggest risks. Medical devices often contain sensitive patient data, which is why they are subject to strict regulations. This data could lead to devastating consequences if it were to become unprotected. SaaS companies who develop medical devices need to take extra precautions to ensure their products are safe.

So who needs to apply for FDA clearance? The FDA defines a ?mobile medical app manufacturer? is any person or entity who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include the app stores.

Software As Medical Device Patenting Considerations

The good news is that investors like medical device companies which have double exclusivity obtained through FDA and US Patent and Trademark Office (USPTO) approvals. As such, the exit point for many medical device companies is an acquisition by cash rich medical public companies. This approach enables medical devices to skip the large and risky go-to-market (GTM) spend and work required to put products in the hands of consumers.

Now that we have discussed the FDA review process, we will discuss IP issues for software medical device companies. Typically, IP includes Patents, Trademarks, Copyrights, and Trade secrets. All of these topics matter and should be considered carefully. However, we will concentrate on patents to demonstrate how careless drafting and lack of planning can lead to problems, namely unplanned disclosures of your design that can then be used as prior art against your patent application.

In general, you should file patent application(s) as soon as practicable to get the earliest priority dates. This will help you when you talk to investors, FDA consultants, prototyping firms, and government agencies, among others. Compliance or other documents filed with any government agency may be considered disclosure to third parties and could make the document public. In general, disclosures to third parties or public availability of an invention trigger a one year statutory bar during which you must file your patent application. Failure to file your application within the required time frame could result in you losing your right to protect your invention.

The information from your FDA application may find its way into FDA databases, including DeNovo, PMA and 510k databases and FDA summaries of orders, decisions, and other documents on products and devices currently being evaluated by the FDA. Your detailed information may be gleaned from Freedom of Information Act requests on your application. This risk mandates that you patent your invention quickly.

When you patent your medical device invention, have a global picture of FDA regulatory framework when you draft your patent application. Be mindful of whether your software/SaaS application discusses the diagnosing and treating patients or affecting the structure or function of the body and add language to indicate that such description in the patent application relates to only one embodiment and not to other embodiments. That way you have flexibility in subsequent discussions with the FDA if you want to avoid classification of your software/SaaS/software as a medical device. In this way, if you wish to avoid FDA registration and oversight, you have the flexibility to do so.

An experienced attorney can assist you in navigating the regulatory landscape and ensure that you comply with all applicable laws. This area of law is complex and constantly changing. It is important that you seek legal advice if you have any questions about whether or not your software should be registered with FDA.

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