Decision Diagnostics Corp (DECN)

[Hopefull17]

What does 'FDA cleared' mean?

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 Samsung wanted to create an app that can record a singlechannel electrocardiogram (ECG, aka EKG), which is what Apple's ECG app does. It could get FDA clearance if it can compare its product to Apple's and demonstrate that it is safe, effective and equivalent in how it works.

Companies must submit a "premarket notification submission" or 510(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 above is from https://www.cnet.com/news/fda-approved-vs-fda-cleared-whats-the-difference/