The artical says "surgical innovations" which probably means instruments and procedures. Also "some implants" are exempt from showing efficacy in clinical trials under HDE for cases in which the patient would have died anyway (e.g. pacemakers).

All medical devices of Class 2 and 3 must go through clinical trials to prove safety and efficacy as part of the FDA IDE. Spinal implants would certainly be Class 3.

Edit: clarification

How about if the implant kills the patient?

There was a local story today about a pacemaker where the electrode had failed and he was defibrilated 47 times during 3 hours before the battery ran out.

I assume/hope they have saved much more lives than that but regardless the types of failures seems to indicate that a lot more could be demanded of these products.

http://www.tellerreport.com/news/---83-000-deaths-in-unsafe-...

That’s a gross oversimplification. Yes, certain devices don’t need to go through clinical trials since their approval is based on a “predicate device” and only involves minimal changes not expected to greatly change the risk-benefit offered.

If you’re developing a brand new, never seen before device, you will have to conduct clinical trials.

> “The few devices that get attention at any time in the press is fewer than the devices we may put on the market in a single business day. That to me doesn’t say that the system is failing. It’s remarkable that the system is working as it does.”

The bigger problem seems to be responding quickly (or responding at all) to real life injuries/issues with medical devices than the approval process.