How to Know if Your Product is a Medical Device
Want to know if your medical product is a medical device in the eyes of the FDA? This article will show you how to identify whether it can be considered a medical device and if so, whether it would be classified as a Class I, II, or III.
First is how to determine if your medical product is considered a medical device in the eyes of the FDA. The FDA considers any device that is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease” as a medical device.
If your product meets this criteria, then you will need to search the FDA’s Product Code database. The Product Code database is begins with selecting the medical specialty where the device is primarily used. A product code is a three-letter designation for a type of medical device, identified by Product Indication (what medical condition it is used to treat) and Intended Use (how the product is administered). In some cases, the FDA doesn’t have a Product Code for your type of device, and it may be for one of two reasons: 1) Your device is novel, meaning that no devices with similar indications or use have yet been submitted to the FDA; or 2) Your product does not meet the definition for a Medical Device.
Products that do not meet the definition for a Medical Device are not regulated by the FDA.
Examples of non-devices that may see to be devices include exercise or dieting apps installed on your phone, workout gear/gym equipment, beauty aids such as eyelash curlers, and air/water filtration devices for general use.
If you are sure that your product meets the definition for of Medical Device and there is no existing product code, you may need to obtain FDA clearance using a De Novo route. A De Novo device is a device that has no substantial equivalence with an existing device (i.e., no devices of its type are yet recognized by the FDA.) Any device without a product code must go through the De Novo route, no matter its risk level. The FDA determines the risk level based on product Class. Class I medical devices are considered to be low risk and are thus subject to the least regulatory controls., for example, crutches. Class II medical devices present more of a moderate risk and have more controls than Class I devices, for example, an infusion pump. Lastly, Class III medical devices pose the greatest risk and have the most stringent controls, for example, an implantable defibrillator.
If you suspect you have a De Novo device, it is recommended to propose a classification for the device if it is Class I or Class II, you can submit an application to request classification for your device. It is recommended, before submitting your application to request a pre-submission meeting with the FDA to communicate your intent to file a classification request and propose your strategy and rationale. In this way, both the FDA and the submitter have an opportunity to discuss the strategy and identify clarifications that will help facilitate classification request and eventual De Novo submission.
There are three medical device classes – Class I, II, and III – which are determined by the level of control necessary to assure safety and effectiveness.
Class III medical devices are those that support or sustain human life, are implanted, or present a potential unreasonable risk of illness or injury. These devices generally must go through the most rigorous approval process before they can be marketed. The FDA requires these devices to undergo Premarket Authorization (PMA) to approve the device before it is placed into interstate commerce.
Class II medical devices present a moderate risk to patients and require special controls in addition to general controls when necessary to provide a reasonable assurance of safety and effectiveness. The FDA generally requires these devices to undergo Premarket Notification (510(k)) to notify the FDA that these devices are being placed into interstate commerce.
Class I medical devices present minimal risks to patients and pose little or no threat of injury or illness. General controls alone are usually sufficient to provide a reasonable assurance of safety and effectiveness. The FDA requires device registration, but does not require specific safety and effectiveness data for these devices
Finally, unclassified medical devices are those that do not fit into any of the above categories. An example of an unclassified medical device would be a simple stethoscope. Manufacturers of unclassified devices did not need to submit a licensing applications to the FDA at the time they were grandfathered by the FDA (May 28, 1976) but new manufacturers of unclassified devices since the enactment date need to submit a Premarket Notification (510(k)).
Regardless of your medical device classification, all medical devices must be registered with the FDA before they can be legally marketed in the United States. The process for registration is relatively straightforward and is outlined on the FDA website. A regulatory consultant can also provide some essential guidance throughout this process and help you work with the FDA to get your device registered and approved as exponentially as possible.
What you need to do if your product is a medical device
-Determine if your product is a medical device
-Identify its product code and which class it falls into
-Register the device with the FDA
-Work with a regulatory consultant to help streamline the process, especially to file the 510(k) or PMA.
-Ensure that you have all of the necessary controls in place to ensure safety and effectiveness.
-If you are unsure as to which category your product falls into, you can contact the FDA for guidance.
The benefits of registering your product as a medical device
-Proper regulatory clearances are required to legally market a medical devivce in the United States.
-Additionally, registering your product as a medical device will help to ensure that it meets all safety and efficacy standards.
-This, in turn, will help to protect patients from potential harm.
-It is important to note that medical devices are subject to a variety of different regulations, so it is important to consult with a regulatory consultant before you begin the process of marketing your device. They can help you navigate the complex maze of FDA regulations and ensure that you are in compliance with all applicable laws.