Which part of this is...

Which part of this is wrong?

https://www.drugwatch.com/fda/510k-clearance/

Premarket Approval vs. 510(k)

The two main avenues for the FDA to allow medical devices to be marketed in the U.S. are known as Premarket Approval (PMA), which requires clinical and laboratory studies and a detailed process to determine safety and effectiveness. On the other hand, 510(k) does not require any of that.

In fact, researchers have found that devices cleared through the 510(k) process are 11.5 times more likely to be recalled than devices that were subject to the more rigorous PMA process.

Also known as premarket notification, Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA at least 90 days before marketing their new products unless the devices are exempt from 510 (k) requirements.

If a company can prove its device is “substantially equivalent” to another already on the market, it can forego clinical trials and testing, saving time and money. Unlike the more rigorous PMA standard, which is to reasonably ensure safety and effectiveness, the 510(k) standard is to determine whether a device is substantially equivalent to a legally marketed device.

In other words, when the FDA clears a device through 510(k), it is not examining if the product is safe or effective for use in patients. It is just agreeing with the maker’s claim that the device is similar to another device already on the market.