Medical Devices Face New Scrutiny From FDA

This article appeared in the Wall Street Journal on April 8th.
According to the article:

The Food and Drug Administration asked several medical-device makers to justify their products' safety and effectiveness, as part of a move to require tougher evidence standards before products can be sold.

But here is the kicker:

The agency's request comes in response to a 1990 order from Congress that directed the FDA to gather rigorous evidence before a manufacturer can sell medical devices considered to be in the most risky category, known as Class 3.

But despite several attempts during the 1990s, the FDA hasn't finished implementing the law. In the past five years, it allowed hundreds of new Class 3 devices to be sold based on a less rigorous showing -- called a 510(k), after a section of federal law -- that they are "substantially equivalent" to combinations of other products marketed before 1976. Such evidence often is collected in a laboratory, not with a clinical trial in patients.

I know the proverbial wheels of Justice and Government grind slowly...but this is ridiculous.
This law has been on the books since 1990 and the FDA still has not fully implemented it.
And now the FDA is going back to the Manufacturers demanding more data on products that are already approved and on the market.....And these companies may actually have to go back and run Clinical Trials on already approved products.....Incredible!