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In Defense of the 510(k)
The 510(k) process has raised significant questions, been part of a national debate, and the subject of a review from the Institue of Medicine. The latest review concludes that 510(k) is not the problem.MD+DI editorial advisory board member, Larry Pilot has written a white paper titled "Stifling Medical Device Innovation—A Response to Critics of the FDA’s 510(k) Clearance Process."
October 12, 2011
1 Min Read
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The 510(k) process has raised significant questions, been part of a national debate, and subject to a review from the Institute of Medicine. The latest review concludes that 510(k) is not the problem.
MD+DI editorial advisory board member, Larry Pilot has written a white paper titled "Stifling Medical Device Innovation—A Response to Critics of the FDA’s 510(k) Clearance Process."
In it, Pilot examines the 510(k) process, saying there is no systemic problem with the regulatory pathway, regardless of what critics say. In contrast, Pilot argues that FDA is at fault for failures related to the 510(k) system:
"Arguably the most stinging safety criticism that can be made against the FDA is not that the 510(k) clearance process is flawed per se, but that the agency has mismanaged it by occasionally clearing devices that were not in fact substantially equivalent to predicate devices.
"Stifling Medical Device Innovation—A Response to Critics of the FDA’s 510(k) Clearance Process"
Do you agree with Pilot? Got any lingering questions?
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