FDA shuts down 510(k) exemption from Trump-era

The proposed rule change at HHS in January just prior to changing of presidential a administrativos did not make it through #FDA . It will therefore not be published in the federal register and will not come to pass. The class 2 devices proposed to become exempt from premarket notification will no longer have that option as it was proposed. #medtech #meddevice

#fda #510k #regulatoryaffairs #medicaldevice #healthtech

see full article here: https://www.medtechdive.com/news/fda-scraps-trump-era-510k-exemption-bid-in-scathing-dissection-of-flawed/598532/

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