The author makes it sound like this is a bad thing, its not. Clinical trials are extremely expensive, if every device manufacturer had to do a clinical trial many devices would never see the light of day.

This is a cost vs benefit trade-off. A 510k is not an easy process to get through and is still very expensive and requires an enormous amount of documentation, paper work, and justification.

If a device harms a patient, it become a reportable event, and the FDA will come swooping down and shut you down if you are not properly documenting and mitigating hazards.

The alternative is fewer medical devices saving lives.