By Stewart Eisenhart, Emergo Group
Medical device regulators at the FDA have issued final guidance for two device types now qualified to obtain faster market access via the agency’s Safety and Performance Based Pathway.
The two final guidances cover cutaneous electrodes for recording purposes and conventional foley catheters, both Class II devices under the FDA classification system, respectively. Finalized in 2019, the Safety and Performance Based Pathway was developed by U.S. regulators to expand the Abbreviated 510(k) program to provide expedited FDA premarket review for well-understood devices.
Get the full story here at the Emergo Group’s blog.
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