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Evaluation of Automatic Class III Designation (De Novo) Summaries

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a "not substantially equivalent" (NSE) determination in response to a premarket notification [510(k)] submission. Section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), on July 9, 2012, to allow a sponsor to submit a De Novo classification request to the FDA for without first being required to submit a 510(k).

There are two options for De Novo classification for novel devices of low to moderate risk.

  • Option 1: Any person who receives an NSE determination in response to a 510(k) submission may, within 30 days of receipt of the NSE determination, submit a De Novo request for the FDA to make a risk-based evaluation for classification of the device into Class I or II.
  • Option 2: Any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may submit a De Novo request for the FDA to make a risk-based classification of the device into Class I or II, without first submitting a 510(k) and receiving an NSE determination.

Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.

Since 2010, the FDA has begun releasing summary documents for devices classified through the De Novo process. The De Novo summary is intended to present an objective and balanced summary of the scientific evidence that served as the basis for the decision to grant a De Novo request. The De Novo summary also serves as a resource regarding the types of information necessary to support substantial equivalence for device manufacturers that may wish to use the device as a predicate for future 510(k) submissions.

Links to all available De Novo summary documents can be found in the table below.

Device Name DEN# Classification Order Decision Summary
Innovo DEN170049 Classification Order  
Medtronic DUET™ External Drainage and Monitoring System (EDMS) DEN120017 Classification Order Decision Summary
Percutaneous Surgical Set with 5 mm or 10 mm Attachments DEN110016 Classification Order Decision Summary
ViruLite Cold Sore Machine DEN090012 Classification Order  
picoAMH ELISA DEN180004 Classification Order  
Parathyroid Detection (Model PTeye) System DEN170056 Classification Order  
Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System DEN170092 Classification Order  
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports DEN180028 Classification Order  
Bose Hearing Aid DEN180026 Classification Order  
Adaptive Biotechnologies clonoSEQ Assay DEN170080 Classification Order  
Precision Flow® HVNI DEN170001 Classification Order Decision Summary
Acumen Hypotension Prediction Index (HPI) Feature Software DEN160044 Classification Order Decision Summary
Ellipsys Vascular Access System DEN170004 Classification Order Decision Summary
everlinQ endoAVF System DEN160006 Classification Order Decision Summary
CURVE™ Positive Airway Pressure System DEN170089 Classification Order Decision Summary
SkinPen Precision System DEN160029 Classification Order Decision Summary
dermPACE System DEN160037 Classification Order Decision Summary
PrimeStore MTM DEN170029 Classification Order Decision Summary
GeneSTAT.MDx Coccidioides Assay DEN170041 Classification Order Decision Summary
DreaMed Advisor Pro DEN170043 Classification Order Decision Summary
OsteoDetect DEN180005 Classification Order Decision Summary
MolecuLight i:X DEN180008 Classification Order Decision Summary
TrueTear Intranasal Tear Neurostimulator DEN170086 Classification Order Decision Summary
Unyvero LRT Application DEN170047 Classification Order Decision Summary
Irregular Rhythm Notification Feature DEN180042 Classification Order  
ECG App DEN180044 Classification Order  
Brainsway Deep Transcranial Magnetic Stimulation System DEN170078 Classification Order  
MATRx plus DEN170090 Classification Order  
IDx-DR DEN180001 Classification Order Decision Summary
Cala ONE DEN170028 Classification Order Decision Summary
ThermoNeuroModulation (TNM) Device DEN170023 Classification Order Decision Summary
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay DEN170010 Classification Order Decision Summary
BONEBRIDGE DEN170009 Classification Order  
Natural Cycles DEN170052 Classification Order Decision Summary
MALDI Biotyper CA System DEN170081 Classification Order  
Hemospray® Endoscopic Hemostat DEN170015 Classification Order  
IlluminOss Photodynamic Bone Stabilization System DEN160062 Classification Order Decision Summary
AQUABEAM System DEN170024 Classification Order Decision Summary
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) DEN170046 Classification Order Decision Summary
remOVE System DEN160014 Classification Order Decision Summary
Dexcom G6 Continuous Glucose Monitoring System DEN170088 Classification Order  
ContaCT DEN170073 Classification Order Decision Summary
NSS-2 BRIDGE DEN170018 Classification Order Decision Summary
CipherOx CRI™ Tablet DEN160020 Classification Order Decision Summary
Banyan BTI DEN170045 Classification Order Decision Summary
FilmArray Respiratory Panel 2 plus (RP2plus) DEN170017 Classification Order Decision Summary
ContainOR DEN170075 Classification Order Decision Summary
QuantX DEN170022 Classification Order Decision Summary
Ventana MMR IHC Panel DEN170030 Classification Order Decision Summary
ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit DEN160025 Classification Order Decision Summary
reSET DEN160018 Classification Order Decision Summary
Fetal Pillow DEN150053 Classification Order Decision Summary
ClearLLab Reagents (T1, T2, B1, B2, M) DEN160047 Classification Order Decision Summary
D2 Dressing DEN160012 Classification Order  
gammaCore Non-invasive Vagus Nerve Stimulator DEN150048 Classification Order Decision Summary
MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) DEN170058 Classification Order Decision Summary
23andMe Personal Genome Service (PGS) Test DEN160026 Classification Order Decision Summary
Philips IntelliSite Pathology Solution (PIPS) DEN160056 Classification Order Decision Summary
MiSeqDx Universal Kit 1.0 DEN130042 Classification Order Decision Summary
Quantitation of Organophosphate Metabolites in Urine by LC/MS/MS DEN130005 Classification Order Decision Summary
ARK Voriconazole II Assay Test System DEN160033 Classification Order Decision Summary
Embosphere Microspheres DEN160040 Classification Order Decision Summary
Sentinel® Cerebral Protection System DEN160043 Classification Order Decision Summary
Vitamin D 200M Assay for the Topaz System DEN170019 Classification Order Decision Summary
AeroForm® Tissue Expander System DEN150055 Classification Order Decision Summary
Intranasal Tear Neurostimulator DEN160030 Classification Order Decision Summary
ipsogen® JAK2 RGQ PCR Kit DEN160028 Classification Order Decision Summary
Accelerate PhenoTest BC Kit DEN160032 Classification Order Decision Summary
Brain Sentinel Monitoring and Alerting System DEN140033 Classification Order Decision Summary
CINtec Histology DEN160019 Classification Order Decision Summary
Illumina MiSeqDx Platform DEN130011 Classification Order Decision Summary
Dexcom Share Direct Secondary Displays DEN140038 Classification Order Decision Summary
SEEKER System DEN150035 Classification Order Decision Summary
Levita Magnetic Surgical System DEN150007 Classification Order Decision Summary
CleanCision™ Wound Retraction and Protection System DEN150038 Classification Order Decision Summary
Elecsys AMH System DEN150057 Classification Order Decision Summary
SENSIMED Triggerfish® DEN140017 Classification Order Decision Summary
cNEP Airway Management System DEN140024 Classification Order Decision Summary
Sensor Monitored Alimentary Restriction Therapy (SMART) Device DEN150033 Classification Order Decision Summary
Hem-Avert Perianal Stabilizer DEN160005 Classification Order Decision Summary
Ultravision™ Visual Field Clearing System DEN150022 Classification Order Decision Summary
ACCLARENT AERA™ Eustachian Tube Balloon Dilation System DEN150056 Classification Order Decision Summary
Tear Duct Occluder DEN140022 Classification Order Decision Summary
Vioguard Self-Sanitizing Keyboard (Model UVKB50) DEN100013 Classification Order Decision Summary
BD MAX Vaginal Panel DEN160001 Classification Order Decision Summary
APAS Compact DEN150059 Classification Order Decision Summary
BrainPulse, Model 1100 DEN140040 Classification Order Decision Summary
Symphony Device (Models 09-0002-01, 09-0003-01, and 09-0004-01) DEN110011 Classification Order Decision Summary
Trevo ProVue and XP ProVue Retrievers DEN150049 Classification Order Decision Summary
ImPACT and ImPACT Pediatric DEN150037 Classification Order Decision Summary
Permaseal DEN150029 Classification Order Decision Summary
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay DEN150030 Classification Order Decision Summary
QuantideX qPCR BCR-ABL IS Kit DEN160003 Classification Order Decision Summary
EPIC ClearViewTM System DEN150004 Classification Order Decision Summary
Pediatric Vision Scanner DEN130051 Classification Order Decision Summary
WallFlex Biliary RX Fully Covered Stent System RMV DEN150040 Classification Order Decision Summary
Cerêve Sleep System DEN140032 Classification Order Decision Summary
Tear Duct Occluder DEN140022 Classification Order  
B·R·A·H·M·S PCT sensitive KRYPTOR® DEN150009 Classification Order Decision Summary
Esophageal Cooling Device DEN140018 Classification Order Decision Summary
PneumoLiner DEN150028 Classification Order Decision Summary
Amplichek II DEN150058 Classification Order Decision Summary
RELIZORB™ DEN150001 Classification Order Decision Summary
Sonablate® 450 DEN150011 Classification Order Decision Summary
EarLens™ Contact Hearing Device DEN150002 Classification Order Decision Summary
Newa™ DEN150005 Classification Order Decision Summary
INVOcell™ Intravaginal Culture System DEN150008 Classification Order Decision Summary
FilmArray® Meningitis/Encephalitis (ME) Panel DEN150013 Classification Order Decision Summary
BrainScope Ahead 100, Models CV-100 and M-100 DEN140025 Classification Order Decision Summary
EnLite™ Neonatal TREC Kit DEN140010 Classification Order Decision Summary
DigniCap™ Scalp Cooling System DEN150010 Classification Order Decision Summary
Eclipse System DEN140020 Classification Order Decision Summary
NOVA View® Automated Fluorescence Microscope DEN140039 Classification Order Decision Summary
23andMe Personal Genome Service (PGS) Carrier Screening Test for Bloom Syndrome DEN140044 Classification Order Decision Summary
Amigo® Remote Catheter System (Amigo RCS) DEN140009 Classification Order Decision Summary
Prostate Mechanical Imager (PMI) DEN100016 Classification Order Decision Summary
Cognivue DEN130033 Classification Order Decision Summary
Zanza-Click, Mini-Click, Disc-o-Click DEN130019 Classification Order Decision Summary
Reza Band® Upper Esophageal Sphincter (UES) Assist Device DEN130046 Classification Order Decision Summary
SpaceOAR System DEN140030 Classification Order Decision Summary
VasoPrep Surgical Marking Pen DEN130004 Classification Order Decision Summary
Zap-It! DEN100024 Classification Order Decision Summary
HeartFlow FFRCT v.1.4 DEN130045 Classification Order Decision Summary
Eeva® System DEN120015 Classification Order Decision Summary
Infrascanner Model 1000 DEN100002 Classification Order Decision Summary
Zeltiq™ Dermal Cooling Device DEN090002 Classification Order  
AirPurge System DEN080009 Classification Order Decision Summary
Bio-Seal Lung Biopsy Tract Plug System DEN090007 Classification Order Decision Summary
Erchonia ML Scanner DEN090008 Classification Order  
NuMED NuCLEUS and NuCLEUS-X BAV Catheters DEN080015 Classification Order Decision Summary
Hem-Avert Perianal Stabilizer DEN090011 Classification Order Decision Summary
RIDASCREEN Norovirus 3rd Generation EIA DEN110001 Classification Order  
Prostate Mechanical Imager DEN100016 Classification Order Decision Summary
LipiFlow Thermal Pulsation System DEN100017 Classification Order Decision Summary
Steris Verify Spore Test Strip for S40 DEN110002 Classification Order Decision Summary
InBios DENV Detect IgM Capture ELISA DEN100020 Classification Order Decision Summary
AHIP Internal Trigger Point Wand DEN100023 Classification Order Decision Summary
Cabochon System DEN110004 Classification Order Decision Summary
Widex C4-PA Wireless Air-Conduction Hearing Aid DEN100025 Classification Order Decision Summary
Aptus Endovascular Suturing System DEN100026 Classification Order Decision Summary
Restiffic™ Restless Leg Relaxer Foot Wrap DEN110009 Classification Order Decision Summary
ImmunoCAP Tryptase DEN120001 Classification Order Decision Summary
STRATIFY JCV Antibody ELISA DEN120008 Classification Order Decision Summary
Neuropsychiatric EEG-Based Assessment Aid for ADHD (NEBA) System DEN110019 Classification Order Decision Summary
Proteus Personal Monitor Including Ingestion Event Marker DEN120011 Classification Order Decision Summary
PORTRAIT TOXIGENIC C. DIFFICILE ASSAY DEN120013 Classification Order Decision Summary
Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP) DEN120014 Classification Order Decision Summary
DEKA Arm System DEN120016 Classification Order Decision Summary
COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay DEN130002 Classification Order Decision Summary
xTAG® Gastrointestinal Pathogen Panel (GPP) DEN130003 Classification Order Decision Summary
Cefaly - Transcutaneous Electrical Nerve Stimulator DEN120019 Classification Order Decision Summary
AXIOS Stent and Delivery System DEN130007 Classification Order Decision Summary
X-ray Attenuating Cream DEN120022 Classification Order Decision Summary
PillCam® COLON 2 Capsule Endoscopy System DEN120023 Classification Order Decision Summary
Vysis EGR1 FISH Probe Kit DEN130010 Classification Order Decision Summary
FerriScan R2-MRI Analysis System DEN130012 Classification Order Decision Summary
VITEK®MS DEN130013 Classification Order Decision Summary
NEPHROCHECK® Test System DEN130031 Classification Order Decision Summary
Pixel 3 System DEN130015 Classification Order Decision Summary
XSTAT DEN130016 Classification Order Decision Summary
CytoScan® Dx Assay DEN130018 Classification Order Decision Summary
Cerena Transcranial Magnetic Stimulator DEN130022 Classification Order Decision Summary
NeoTract UroLift System, Model REF UL400 DEN130023 Classification Order Decision Summary
Xpert MTB/RIF Assay DEN130032 Classification Order Decision Summary
ReWalk™ DEN130034 Classification Order Decision Summary
Prostate Immobilizer Rectal Balloon DEN130036 Classification Order Decision Summary
EUROIMMUN Anti-PLA2R IFA DEN140002 Classification Order Decision Summary
IOGYN System DEN130040 Classification Order Decision Summary
Lyra™ Direct HSV 1 + 2/VZV Assay DEN140004 Classification Order Decision Summary
Simplexa™ HSV 1 & 2 Direct DEN130049 Classification Order Decision Summary
Lyra Direct Strep Assay DEN140005 Classification Order Decision Summary
KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay DEN140001 Classification Order Decision Summary
STUDIO on the Cloud Data Management Software DEN140016 Classification Order Decision Summary
T2Candida Panel and T2Dx® Instrument DEN140019 Classification Order Decision Summary
inFlow™ Intraurethral Valve-Pump and Activator DEN130044 Classification Order Decision Summary

 

Page Last Updated: 11/15/2018
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