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
Eonis SCID-SMA Kit2022-11-09
INNOVANCE VWF Ac2022-09-29
APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System2022-07-12
ProdiGI2022-06-13
CERAMENT G2022-05-17
BioFire Joint Infection (JI) Panel2022-04-29
Sunrise Sleep Disorder Diagnostic Aid2022-01-07
CavaClear Laser Sheath2021-12-21
EaseVRx2021-11-16
OMNIgene GUT Dx2021-11-03
Luminopia One2021-10-20
Paige Prostate2021-09-21
Canary Tibial Extension With Canary Health Implanted Reporting Processor (CHIRP) System2021-08-27
SureTune4 Software2021-08-23
ADVIA Centaur Enhanced Liver Fibrosis (ELF)2021-08-20
OsteoProbe2021-08-19

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