FDA provides rigorous oversight of medical devices
The Jan. 25 editorial “Left to their own devices” (p. 26) regrettably provides an inaccurate depiction of the safety of medical devices and the Food and Drug Administration’s regulatory process.
The column condemns the FDA for not requiring clinical trial testing for all new medical devices as the agency does for drugs. But devices and drugs are fundamentally different, and there is no reason they should be regulated or evaluated the same way.
Medical technology encompasses everything from tongue depressors to brain stimulators. The FDA targets the amount of evidence required to prove safety and effectiveness to the risk of the device.
For the newest, highest-risk devices, the FDA does require clinical trial testing similar to pharmaceuticals. For lowerrisk devices, companies submit hundreds—sometimes thousands— of pages of scientific evidence covering bench testing, animal studies, biocompatibility testing, etc., that FDA reviews to determine safety and effectiveness.
There is no precedent—no studies, no literature—that shows human trials produce safer devices when those devices have already undergone such rigorous premarket testing.
As science and technology evolve, so does the regulatory system. This industry has and will continue to engage with all stakeholders on process improvements. But to ignore the millions of people over the decades who have benefited from medical technology thanks to the FDA’s rigorous oversight and industry’s commitment to safety does a disservice to the patients we serve.
Scott Whitaker President and CEO
AdvaMed Washington, D.C.