With rising trends in the medical device market such as 3D imaging and telemedicine, the consumer need for information is higher than ever. This article explains the basics of medical device classification and how to make sure your marketing adheres to FDA regulation.
Classification of Medical Devices
When registering your medical device with the FDA, you must self-classify your device using their index of industries and device uses. Depending on what class and industry you are, a specific application process may be required. FDA regulated medical devices are classified into three classes based on:
- Degree of risk posed to the patient or user
- Intended use of the device
- Indications for use
As the device class increases, the FDA’s regulatory controls also increase.
|
Class I |
Class II |
Class III |
|
|
|
Because the risk factor is the highest for class III medical devices, they are considered restricted devices. These devices require a premarket approval process to ensure safety and effectiveness and can only be sold upon oral or written authorization by a licensed practitioner or under conditions specified by regulation. Class I and II are considered unrestricted, meaning they do not need authorization for sale. Therefore, class I and II devices also have fewer marketing and advertising regulations.
|
|
Restricted Devices |
Unrestricted Devices |
|
Labeling |
FDA |
FDA |
|
Advertising |
FDA |
FTC |
|
Internet |
FDA |
FDA & FTC |
Who Has Jurisdiction for Marketing?
The FDA regulates all marketing and communication for restricted devices, labeling of unrestricted devices, and internet and social media presence for unrestricted devices (joint-regulation).
Communication regarding class III devices must coincide with their premarket approval application in order to avoid any concerns with misbranding. Requirements include:
- No false or misleading advertising (claims, comparatives, unapproved uses)
- Must include device name and manufacturer, prominently printed
- Must include a brief statement of the intended uses of the devices and relevant warnings, precautions, side effects, and contradictions
- Can’t promote an off-label use or investigational device (IDE)
No matter what your product’s classification, it is important to present understandable, useful information to your audience. Check out the following list of communication best practices.
5 Best Practices for Medical Device Marketing
1. Introduce the product and explain its purpose
Unless you are a doctor, or read up about life-altering medical devices in your spare time, you may not know why or how a certain technology is used. It’s recommended that manufacturers give a brief statement of an item’s use and any indications with such. This explanation doesn’t need to be long, but to the point and honest. Keep in mind your customer persona, the type of person who would find these details important and helpful.
2. Write to the reader
Write in a way that speaks to your persona. Direct language and specific, valuable points will allow readers to break through the technical lingo and comprehend how your product can help them. The technical writing and documentation experts at Novatek Communications share some great tips for writing for readers.
3. Balance your benefits and risks
Just as your readers should be able to understand the intended use and benefits of a medical device, they should also have clear information about the potential risks and side effects. Make sure your communications provide a complete picture of what your device can, might, and won’t do.
4. Ensure consistency across all targets and channels
No matter how potential customers discover your company or product, they should find the same useful, accurate information. Make sure that details are consistent and up-to-date across channels, from white papers to your website and social media. Provide links to further information where necessary.
5. Have a very thorough editing process
A thorough review and editing process is essential to good marketing communications in regulated industries. Establish roles and guidelines for review, including who has final sign-off on marketing and sales materials.
For more information on premarket requirements and marketing of medical devices, visit the FDA website.
Download our tip sheet, 10 Tips for Connecting with Medical Device Customers.
