Evaluation of Automatic Class III Designation

The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. De Novo classification is a risk-based classification process.

Devices that are classified into class I or class II through a De Novo classification request may be marketed and used as predicates for future premarket notification [510(k)] submissions.

Latest De Novo Classifications

ManufacturerDevice NameDate
Tangible Boost2020-09-24
HemosIL Liquid Anti-Xa2020-09-17
Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer2020-08-28
Cell-Free DNA BCT2020-08-07
NaviCam Capsule Endoscope System With NaviCam Stomach Capsule2020-05-22
NP Screen2020-05-11
ITEAR Neurostimulator2020-05-01
OGmend Implant System2020-05-01
MyCare Psychiatry Clozapine Assay Kit2020-04-16
I-TIND System2020-02-25
AmplideX Fragile X Dx & Carrier Screen Kit2020-02-21
Surfacer Inside-Out Access Catheter System2020-02-10
Caption Guidance2020-02-07
Mucosal Integrity Conductivity (MI) Test System2019-12-23
Control-IQ Technology2019-12-13
GSP Neonatal Creatine Kinase - MM Kit2019-12-12
Cobas VivoDx MRSA2019-12-05
WOUNDCHEK Bacterial Status2019-12-02
EchoTip Insight Portosystemic Pressure Gradient Measuring System2019-11-20

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