How a device is classed from how a device is classwide follows how strict
the requirements are for that particular device, and
not all devices actually have FDA approval.
Some devices go through the riskiest, class three devices generally
go through what's called the pre-market approval process.
It's also known as a PMA.
Generally, that means that the manufacturer has conducted at least one
clinical trial, to show that there is a reasonable assurance that the device
is safe and effective for its intended use.
And FDA actually approves those.
And it's somewhat similar to what folks are generally familiar with
in the drug context, how FDA generally approved prescription drugs.
But a number of devices go through a different process,
known as a 510k process.
Generally, these are class two devices, but not always.
And that is a process where FDA authorizes the marketing of the product.
But it's not a formal approval based on the safety and
effectiveness of the product.
It's an approval saying,
you are substantially equivalent to another device that is already marketed.
So rather than demonstrating through clinical trials that your device is safe
and effective, you demonstrate that it is substantially equivalent to something that
is already marketed.
Many class one devices, many of the lowest risk devices,
don't even go through that process.
So Bandaids, for example, likely don't have to go through that process.
And FDA has regulations that tell you which devices have to go through the 510k
pre-market notification process, and which devices don't.