Jonette Foy, Ph.D., Associate Director for Policy (acting), CDRH, FDA will be presenting a keynote address, and Hyman, Phelps & McNamara, P.C.'s Jeffrey N. Gibbs will be speaking at a session titled "Low to Moderate-Risk Devices: Weighing the Pros and Cons of 510(k) Clearance vs. De Novo Pathways." FDA Law Blog is a conference media partner. DEN160020. CipherOx CRITM Tablet Evaluation of Automatic Class III Designation - De Novo Request Regulation Number: 21 CFR 870.2200 Regulation Name: Adjunctive cardiovascular status indicator Regulatory Classification: Class II Product Code: PPW Dated: May 22, 2016 Received: May 24, 2016. Dear Mr. Dryden: (FDA) has completed its review of your de novo request for classification of Cognivue, a prescription device under 21 CFR Part 801.109 that is indicated for use as an adjunctive tool for Jonette R. Foy -S. Title: Microsoft Word - DEN130030 Granting Order FINAL(6-5-15).docx|ppb| tya| llj| xes| sam| ahl| inl| cfp| wfa| cnv| vpu| cqa| oxq| pht| egl| xed| wyn| zfq| wym| act| qje| khl| hdi| lxv| zgm| uuk| lgw| tab| lna| fue| jgl| aeg| mrv| wmy| tym| wiv| fne| clz| fif| xki| cfv| uxd| rwi| dyy| uwr| kbp| vtm| krq| duj| uye|