When Technology Meets Medicine: 5 Regulatory Items to Look Out For
Many medical and digital health companies are moving into the realm of medical devices. Medical devices are an exciting, lucrative field with plenty of potential for new research and product development. It's no wonder companies like Samsung and Misfit (recently acquired by Fossil) are moving into the market.
There are many medical device regulations to protect consumers, especially in the United States. Some of these are on the state level, but most are handed down by the Food and Drug Administration (FDA). It's important to educate yourself extensively about regulatory requirements before entering the initial phases of your product's creation.
Remember that regulations are very complicated and can change quickly, and this is just an overview of some of the important items. You should always check to make sure your products conform to up-to-date FDA and state-level standards, and if you have questions, you should consult with a regulatory expert.
Why Regulate Medical Devices?
Many medical items diagnose medical conditions or provide other useful medical information to physicians or consumers. Consumers need accurate access to information, both to know about potentially serious medical problems and to avoid health scares or unnecessary treatments.
Medical devices that treat diseases are particularly important to regulate. They may, for instance, help doctors, nurses or patients administer doses of a medicine or another substance. That substance needs to be administered safely and at the proper dosage.
Finally, keep in mind that some things that may seem like medical devices don't actually qualify as medical devices in the eyes of the FDA. In this case, they're free of regulatory requirements. If you're uncertain if your product qualifies as a device, it's always best to contact the FDA for an official ruling.
Five Important Regulatory Items
There's a multitude of requirements put in place by the FDA, all of which medical device designers and manufacturers should keep in mind. Here are five of the important ones:
- If your device is what the FDA defines as a medical device, then it, as well as your company, needs to be properly registered by the FDA. They need to know about it so they can regulate it appropriately, and you need to know exactly how your device is classified by the FDA in order to effectively maintain a regulated quality system.
- The rules surrounding the labeling of medical devices are strict and extensive. As an example, you should always make sure that a medical device comes with documentation, including instructions for use, that's clear enough that a layperson should be able to operate it. (The final determination of what that means is up to the FDA.) You should also be sure that all labels are large and easily readable.
- Device Tracking. For certain classes of medical devices, manufacturers must implement a tracking system that allows them to promptly locate commercially distributed devices in order to facilitate notifications and recalls ordered by the FDA. This is particularly important if the failure of the device could have lethal consequences, if the device is to be implanted in a body for longer than a year, or if the device is life-sustaining and used outside of a medical facility.
- Device Reporting. In order to detect and correct problems in a timely manner, medical device manufacturers, importers, and use facilities must submit reports to FDA of any adverse reactions or deaths that occur in association with the product.
- Design History File. One of the most important parts of a comprehensive FDA regulated quality system is a Design History File, which compiles all records that describe the design history of a finished medical device. A device’s DHF includes documentation of verification activities, design reviews and change orders, and all other records of design control that cover the entire life of a device, including any changes that may occur long after a product has been introduced to market.
The rules surrounding the regulation of medical devices may seem confusing or even arbitrary to many industry professionals. However, FDA regulations are of vital importance to protect consumers.
Business owners and product designers should make sure to educate themselves extensively about the FDA's regulatory requirements, as well as any state-level regulations for manufacturers and distributors. By doing this, you'll avoid potentially expensive lawsuits down the line, as well as damaging bad press.