That's right! Just like the title stated, Carepod One - Stainless Steel Humidifier has just received FDA clearance in the regulation medical specialty of anesthesiology. This is a huge step forward for both the company and all our customers. We love sharing about how simple and easy-to-clean our product is because we realize the importance of cleanliness and overall health. Therefore, we have been pursuing the FDA's approval of our product for the last several months to further provide you with that sense of safety and trust in Carepod.
The US Food and Drug Administration takes measures to ensure public health safety such as regulating medical devices to assure a products effectiveness. The organization compiles many studies and imposes regulations on a variety of products and their relative classifications. This includes foods and medication, cosmetics, supplements, medical devices, cellular devices, and more.
The FDA categorizes medical devices into one of three classes – Class I, II, or III. The amount of regulation that provides a reasonable assurance of the device's safety and effectiveness is one of the factors that the FDA uses to classify medical devices. You may be asking... Well, what differentiates those classes from one another? According to the FDA:
- Class I — Devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process.
- Class II — Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 43% of medical devices fall under this category. Products of this class typically require more regulatory control and are of greater complexity than Class I devices.
- Class III — These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.
Carepod receiving FDA approval is a huge accomplishment and we are thrilled to share it with you all! We have a lot planned for the future and hope you'll stay for the ride. You can stay informed by following our blog.
You can see specific product clarification from FDA here.