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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 devices of low to moderate risk 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 novel low to moderate risk devices 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
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  
ViruLite Cold Sore Machine DEN090012 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
Symphony Device (Models 09-0002-01, 09-0003-01, and 09-0004-01) DEN110011 Classification Order Decision Summary
ImmunoCAP Tryptase DEN120001 Classification Order Decision Summary
Percutaneous Surgical Set with 5 mm or 10 mm Attachments DEN110016 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  
COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay DEN130002 Classification Order Decision Summary
xTAG® Gastrointestinal Pathogen Panel (GPP) DEN130003 Classification Order Decision Summary
Quantitation of Organophosphate Metabolites in Urine by LC/MS/MS DEN130005 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
Illumina MiSeqDx Platform DEN130011 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
MiSeqDx Universal Kit 1.0 DEN130042 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
STUDIO on the Cloud Data Management Software DEN140016 Classification Order Decision Summary
KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay DEN140001 Classification Order Decision Summary
inFlow™ Intraurethral Valve-Pump and Activator DEN130044 Classification Order Decision Summary

 

Page Last Updated: 12/15/2014
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