"As we’ve long noted, both devices were approved through a fast-track process known as the 510(k), which means that a formal review for safety and efficacy was neither required nor performed." What total fucking bullshit... It took 6 years to reach 510(k) clearance for a full implant & instrumentation system as an Engineer at Zimmer (granted, it did have 50,000 SKUs...), and now at another company I'm 2 years into a 510(k)-tracked implant system and we are finally finishing up verification and validation testing. The fact that the auto industry can release whole new cars in less time than the med device industry can release the simplest of Class II (510k) implant systems is BECAUSE we have to spend so much time proving safety and efficacy. I've lost track of how many times I've had to perform mechanical testing on needles and guide wires just to prove "even if the surgeon is a dumbass, the product won't break." My jimmies are rustled.
