Regulatory Classification of Medical Devices
There are a variety of regulatory agencies and each has defined various classifications for medical devices. Traditionally, the rules that apply to your specific medical device are dependent on how your device/ product is classified by the regulatory agencies. The easiest way to think about how classification works is generally related to perceived risk of the product type that you are bringing to market. Medical device manufacturers selling products and/ or services both domestically and internationally need to ensure that they acquaint themselves with relevant regulations of each market. Although there is some similarity between international medical device regulations, there are different sets of rules depending on which market you are attempting to sell in. For example, the United States has its own regulatory rules and standards that differ from the regulations that Canada adheres to, along with Europe.
When thinking about registering a medical device with the Food and Drug Administration (FDA), your team must understand how to utilize the FDA’s index of industries and device use to self classify your device. The FDA classifies medical devices into three different classifications such as Class I, Class II and Class III; which are all dependent on three important factors.
- Intended Use is considered the general purpose of the medical device or its function.
- Indications for Use describes the disease or condition the medical device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population.
- Degree of Risk is the combination of probability of occurrence of harm and the severity of that harm
Here is a quick chart to help you better understand the different classifications and how they relate to the different elements.
The amount of regulations that there are for marketing and advertising medical devices directly corresponds with the risk factor of each medical device. Class I and Class II medical devices are considered unrestricted therefore, they do not need any authorization for sale in the market. With that, comes less marketing and advertising regulation. In contrast, since the level of risk is the highest in the Class III classification, they are characterized as restricted devices which require a premarket approval from the FDA to ensure effectiveness of the device and overall safety of use. Class III medical devices are only allowed to be sold with either a written and/ or oral authorization from a licensed professional or practitioner or under a variety of circumstances that are specified by FDA regulation. The marketing and advertising route with these kinds of devices is therefore regulated significantly more.
Have a clear understanding on marketing jurisdiction for medical devices
Having knowledge about the difference between the FDA and The Federal Trade Commission (FTC) is important to know so your team understands who regulates which areas of your marketing and advertising initiatives. The FTC enforces a variety of antitrust and consumer protection laws, affecting virtually every area of commerce, with some exceptions concerning banks, insurance companies, non-profits, transportation and communication common carriers, air carriers, and some other entities.” The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.
Restricted devices in Class III are all regulated by the FDA, who oversees all marketing and advertising communications that are distributed. They also regulate both labeling, internet and social media content, while the FTC regulates advertising, internet and social media presence for unrestricted devices in a joint regulation infrastructure.
Communication with Class III medical devices must be identical to what appears on your premarket approval application. Ensuring that this is always top of mind will be extremely helpful to bypass any branding concerns when creating any marketing or advertising collateral. Your team needs to make sure that your efforts are always in compliance with FRA requirements. These requirements include:
- No false labeling or misleading in any instances
- Must contain the name and place of business of the manufacturer, packer, or distributor
- Required wording is prominently displayed
- Must bear adequate directions for use including warnings, precautions, side effects and any contradictions
- No promotion of any off-label use cases
- No marketing or advertising of any Investigational Device Exemption (IDE)
Whether your medical device is an unrestricted Class I device or a restricted Class III device we recommend that you always provide clear, transparent and understandable information to your target audience, in order to keep them informed and to avoid any concerns with misbranding in any instance.
Best Practices for Advertising and Medical Device Marketing
1. ANNOUNCE YOUR MEDICAL DEVICE AND DESCRIBE ITS PURPOSE IN MARKET
With the medical device world being so crowded there is a lot of clutter that consumers have to navigate through. When developing introductory messaging, it is important to remember your customer personas and who it will resonate with most. Think about who will think the information is educational, important and useful. It’s recommended that you or the manufacturer, provide a brief statement of the devices intended use and indications for use. You really want to develop information that is both straight to the point and provides value.
2. PORTRAY THE RIGHT MESSAGING TO YOUR TARGET AUDIENCE
You do not want your messaging to cause confusion with too little information nor diluted with too much. It’s easy to go down the rabbit hole with technical information that your audience may find hard to understand. Try to implement tactics to find a healthy balance to create valuable information that will enable your target audience to be engaged and craving additional information.
3. ENSURE FULL TRANSPARENCY & BALANCED COMMUNICATION
Your audience wants to understand all the benefits that your medical device would bring to market, but also remember that you need to be completely transparent about any associated risks and/ or side effects. It is important that misbranding is not a concern and that your audience has the opportunity to gain complete insight on what your device is capable of, has potential to do and will not do. This way you enable them to make a fully educated and informed decision for themselves.
4. CONSISTENT BRANDING AND MESSAGING ACROSS ALL MARKETING AND ADVERTISING COMMUNICATIONS
Potential customers are going to find your company and device from a variety of different sources from in-person events to digital outlets like your website, social media platforms and paid advertising. You want to ensure that all communications are accurate and up-to-date across all marketing and advertising channels to eliminate any chance of confusion.
5. DEVELOP A CONTENT REVISION AND APPROVAL SYSTEM
In a regulated industry such as medical devices, it is critical that you have a comprehensive system in place for content revisions, editing and final approvals. Implementing a system like this to support all marketing communication outlets can make or break your device's credibility and reputation.