Today, the FDA CDRH released a report produced by the independent Institute of Medicine about the FDA 510(k) clearance process for devices. Although this document is not specifically about diagnostic assay devices (it covers all devices from MRI systems to pregnancy test), its main conclusion that the 510(k) clearance process is flawed will most likely have an impact on the approval of future diagnostic method derived from biomarker research.
Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years - Institute of Medicine
Thierry
Sornasse for Integrated Biomarker Strategy
At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.click here More..........
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