Re:Patients shocked, burned by spinal cord stimulators toute...
by refurb on Sunday November 25, 2018 @08:35PM
(#18530354)
Unlike drugs, implants don’t need to go through clinical trials in most cases.
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.
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.