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 It will therefore not be published in the federal register and will not come to pass.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/

Thomas Regulatory Resolutions (TRR) is a lean medical device consulting firm serving the medical device industry by providing value-added consulting services to medical device manufacturers for FDA submissions, FDA Compliance 510(k), Establishment Registration, FDA US Agent, CE Marking per EU MDR 2017/745 and Clinical Evaluation Reports (CERs) per MEDDEV 2.7/1 among other regulatory services.

Count on us for all of your medical device regulatory submission needs.

You may contact us via phone at +1 561 898 0260 or email dallas@thomasregulatory.com or if you are ready now to schedule a free 30 minute appointment with us, please do so here: https://thomas-regulatory.appointlet.com and we are standing by to support your medical device regulatory and compliance needs.