Saving an average of 100 review days
We understand the need for industry to obtain FDA clearance as soon as possible. Since the inception of TPRG, submissions reviewed by FDA averaged approximately 163 days. During this same time, submissions reviewed by TPRG averaged 65 days
Zero MDUFA Fee [FDA cost waived].
Applicants are exempt from paying the FDA MDUFA fee when they submit their 510(k) directly to TPRG in lieu of FDA saving them precious review time and expediting their device clearance into US commerce.
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