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
Canary Tibial Extension With Canary Health Implanted Reporting Processor (CHIRP) System2021-08-27
InSpace Subacromial Tissue Spacer System2021-07-12
BioFire Respiratory Panel 2.1 (RP2.1)2021-03-17
Analytic For Hemodynamic Instability (AHI)2021-03-01
Lumenis Stellar M222021-02-23
CADScor System2020-11-24
FilmArray Global Fever Panel2020-11-20
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

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