Complex medical devices that are implanted in your body, life-sustaining, or have the potential to cause significant injury or illness in the body are in Class III. Those include implanted pacemakers, replacement heart valves and even breast implants. Lower-risk devices and products used outside of the body, like condoms, motorized wheelchairs and catheters, fall into Class II and Class I. Class II and Class I medical devices are usually "cleared" by the FDA, which means the manufacturer can demonstrate that their product is " substantially equivalent to another similar legally marketed device" that already has FDA clearance or approval.
Those already-cleared products are called a predicate. For instance, let's say hypothetically Apple wanted to create a blood pressure monitor, using the same design and features of one that already exists. The company could get FDA clearance if it can compare its product to another that's already on the market and demonstrate that it is it just as safe and effective, and works in the same way.
Companies must submit a "premarket notification submission" or k to the FDA so that it can review the product and clear it. Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is "cleared," and can be marketed and sold in the US.
The problem with the FDA's approval system, as John Oliver pointed out, is that often companies get their product cleared by using older predicates that were later recalled for safety reasons. Just because a device was FDA approved or cleared does not always mean it is safe. That's why you see ads for class-action lawsuits asking if you or a loved one used a FDA-approved product, and suffered permanent bodily harm or died as a result.
Those defective products ended up causing significant health problems, even though they were cleared or approved. FDA Cleared: When used correctly, this term refers to FDA allowing a device to market through the k process based on substantial equivalence to a legally marketed predicate device.
It doesn't sound as glamorous as "FDA approved," but "clearance" is a critical step on the path to market for many devices. A device that is truly "cleared" may not have FDA's affirmative blessing, but it has certainly passed a basic level of scrutiny and the door is now open to market. But many devices, especially health and wellness or even k exempt devices, erroneously claim that they are FDA "cleared.
If the device never required a k clearance in the first place, the words "FDA cleared" are meaningless. Here's a device being sold at a major online retailer that claims to be both "class I" and "cleared. So adding words like "FDA cleared" to the marketing material may sound good, but they do not represent that FDA has taken any activity toward the device. Granted: The term "granted" is used by FDA to describe a favorable outcome to a de novo classification request.
This means that a company has successfully worked with FDA and that their device can be safely marketed through general controls or general controls and special controls without demonstration of substantial equivalence.
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