FDA Definition of a Medical Device

Section 201(h) of the Federal Food, Drug, and Cosmetic Act21 U.S.C. 321(h)(1), defines a medical device as:

“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

If the product meets these requirements, it will be regulated by the FDA as a medical device and is subject to all laws and regulations of the FDA before, during, and after it is sold or used in the United States.

Medical devices can range from simple hospital gowns and tongue depressors to more complex programmable pacemakers or robotic surgical systems. The Medical Device Product Classification Database contains over 6,000 medical devices that are regulated by FDA’s Center for Medical Devices and Radiological Health (CDRH). Each type is also listed with the class assigned.

Based on device classification and other factors, federal regulations (such the Code of Federal Regulations Title 21) establish requirements that must be met for CDRH approval or clearance of devices sold in the United States.

FDA Definition of a Software Medical Device

The FDA refers to software functions that can include “Software as a Medical Device” (SaMD), and “Software in a Medical Device (SiMD) ), which is software that is integral to (embedded in) a medical device.  To be considered a medical device and therefore subject to FDA regulation, your software must meet one of two criteria:

  • It must be intended for use in diagnosing or treating a patient; or
  • It must be intended to affect the structure or any function of the body

Thus, if your software is specifically designed for healthcare professionals to diagnose and treat patients or used in hospitals to manage patient information, the FDA would likely view such software as medical devices subject to regulatory review.

Is Your Software a Medical Device?

In general, the FDA applies its regulatory oversight to medical devices with functionality that could be dangerous to patient safety, in accordance to the FDA’s current oversight, which looks at the functionality of the software more that the platform. Examples of Device Software and Mobile Medical Apps scrutinized by the FDA include:

  • Software functions that aid patients with diagnosed mental disorders (e.g., depression, anxiety, and post-traumatic stress disorder (PTSD), etc.) by providing “Skill of the Day”, a behavioral technique, or audio messages, that the user can access when they are experiencing anxiety.
  • Software functions that offer periodic reminders, motivational guidance, and educational information to patients who are recovering from addiction or smokers who want to quit.
  • Software functions that use GPS location data to alert asthmatics when they are near high-risk locations (substance abusers), or to alert them of potential environmental conditions that could cause symptoms.
  • Software that uses video and games to encourage patients to exercise at home.
  • Software functions that prompt users to choose which herb or drug they wish to take simultaneously. They also provide information about interactions and give a summary of the type of interaction reported.
  • Software functions that take into account patient characteristics, such as gender, age, and risk factors, to offer patient-specific counseling, screening, and prevention recommendations from established and well-respected authorities.
  • Software functions that use a list of common symptoms and signs to give advice about when to see a doctor and what to do next.
  • Software functions that help users to navigate through a questionnaire about symptoms and to make a recommendation on the best type of healthcare facility for them.
  • These mobile apps allow users to make pre-specified nurse calls or emergency calls using broadband or cell phone technology.
  • Apps that allow patients or caregivers to send emergency notifications to first responders via mobile phones.
  • Software that tracks medications and provides user-configured reminders to improve medication adherence.
  • Software functions that give patients access to their health information. This includes historical trending and comparisons of vital signs (e.g. body temperature, heart rate or blood pressure).
  • Software functions that display trends in personal healthcare incidents (e.g. hospitalization rates or alert notification rate).
  • Software functions allow users to electronically or manually enter blood pressure data, and to share it via e-mail, track it and trend it, and upload it to an electronic or personal health record.
  • Apps that offer mobile apps for tracking and reminders about oral health or tools to track users suffering from gum disease.
  • Apps that offer mobile guidance and tools for prediabetes patients.
  • Apps that allow users to display images and other messages on their mobile devices, which can be used by substance abusers who want to quit addictive behaviors.
  • Software functions that provide drug interaction and safety information (side effects and drug interactions, active ingredient, active ingredient) in a report based upon demographic data (age and gender), current diagnosis (current medications), and clinical information (current treatment).
  • Software functions that allow the surgeon to determine the best intraocular lens powers for the patient and the axis of implantation. This information is based on the surgeon’s inputs (e.g., expected surgically induced astigmatism and patient’s axial length, preoperative corneal astigmatism etc.).
  • Software, usually mobile apps, converts a mobile platform into a regulated medical device.
  • Software that connects with a mobile platform via a sensor or lead to measure and display electrical signals from the heart (electrocardiograph; ECG).
  • Software that attaches a sensor or other tools to the mobile platform to view, record and analyze eye movements to diagnose balance disorders.
  • Software that collects information about potential donors and transmits it to a blood collection facility. This software determines if a donor is eligible to collect blood or other components.
  • Software that connects to an existing device type in order to control its operation, function, or energy source.
  • Software that alters or disables the functions of an infusion pump.
  • Software that controls the inflation or deflation of a blood pressure cuff.
  • Software that calibrates hearing aids and assesses sound intensity characteristics and electroacoustic frequency of hearing aids.

What does this mean?

SaaS founders must be aware of the compliance risk that medical devices present. Data breaches are the greatest risk. Data breaches are a major risk. Medical devices can often contain sensitive patient information, so strict regulations apply. If this data is not protected, it could have devastating consequences. SaaS companies that develop medical devices must take extra precautions in order to protect their products.

Who is required to apply for FDA clearance?

A “mobile medical app maker” is defined by the FDA as any person or entity that initiates specifications, designs or labels a software system or application to a regulated device. This could be from one or more software components. This does not include people who distribute only mobile medical apps and do not engage in manufacturing functions. Examples of such distributors include the app stores.

Software as Medical Device Patenting Considerations

Investors love medical device companies that have dual exclusivity through FDA and US Patent and Trademark Office approvals. Many medical device companies are looking to be acquired by cash-rich medical public companies. Medical devices can avoid the risky and expensive go-to-market (GTM), spend and labor required to get products to consumers.

Now, let’s talk about IP issues for software companies that make medical devices. IP typically includes patents, trademarks, copyrights and trade secrets. These topics are important and must be carefully considered. We will focus on patents because we want to show how poor drafting and lack planning can lead to problems. Unplanned disclosures of your design can then be used against your patent application as prior art.

To get the earliest priority dates, it is best to file your patent application(s), as soon as possible. This will make it easier to talk with investors, FDA consultants and prototyping companies, as well as government agencies. Documents filed with any government agency or compliance documents could be made public and may be considered disclosure to others. Public disclosures or availability of an invention to third parties can trigger a one-year statutory bar that you must comply with in order to file your patent application. You could lose your right to protect the invention if you fail to file your application within this time limit.

Your FDA application information may be included in FDA databases. These databases include DeNovo, PMA, 510k, FDA summaries, orders, decisions, FDA summaries, and documents about products and devices that are currently under FDA evaluation. Freedom of Information Act requests may allow you to obtain more detailed information about your application. This is why it is important to patent your invention as soon as possible.

When patenting your medical device invention, you should have a complete understanding of the FDA regulatory framework. Make sure your software/SaaS applications do not discuss the diagnosis and treatment of patients. If so, you should add language to indicate that the description in the patent application is only for one embodiment. 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. This allows you to choose whether or not you want to register with FDA and be subject to oversight.

An experienced attorney will help you navigate the regulatory landscape and ensure you comply with all applicable laws. This area of law changes constantly and is complicated. If you have questions about whether your software should register with FDA, it is important to seek legal advice.

PatentPC’s sole vision is to help startups succeed through IP. Our own AI tools have been developed to aid our patent workflow and guide us through the government agencies. Our patent and business lawyers have extensive experience in software, SaaS and medical device technology. We offer flat-fee legal services for startups, businesses, as well as intellectual property. We don’t track time because there are no hourly charges and no charges for calls or emails. We are focused on getting you the best possible legal work.

Our experience includes advising established businesses on intellectual property and regulatory issues, as well as helping startups in their early years. Our lawyers have extensive experience in assisting entrepreneurs and startups. Contact us at 800-234-3032 for a confidential consultation or to make an appointment.