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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 File Number Classification Order Decision Summary
Infrascanner Model 1000 K080377 Classification Order Decision Summary
Zeltiq™ Dermal Cooling Device K080521 Classification Order  
AirPurge System K080644   Decision Summary
Bio-Seal Lung Biopsy Tract Plug System K082438 Classification Order Decision Summary
Erchonia ML Scanner K082609 Classification Order  
NuMED NuCLEUS and NuCLEUS-X BAV Catheters K082776 Classification Order Decision Summary
Hem-Avert Perianal Stabilizer K083692 Classification Order  
ViruLite Cold Sore Machine K083767 Classification Order Decision Summary
RIDASCREEN Norovirus 3rd Generation EIA K093295 Classification Order  
Prostate Mechanical Imager K093579 Classification Order Decision Summary
LipiFlow Thermal Pulsation System K093937 Classification Order Decision Summary
Steris Verify Spore Test Strip for S40 K100049 Classification Order Decision Summary
InBios DENV Detect IgM Capture ELISA K100534 Classification Order Decision Summary
AHIP Internal Trigger Point Wand K100934 Classification Order Decision Summary
Cabochon System K101231 Classification Order Decision Summary
Widex C4-PA Wireless Air-Conduction Hearing Aid K101699 Classification Order Decision Summary
Aptus Endovascular Suturing System K102333 Classification Order Decision Summary
Symphony Device (Models 09-0002-01, 09-0003-01, and 09-0004-01) K102873 Classification Order Decision Summary
ImmunoCAP Tryptase K103039 Classification Order Decision Summary
Percutaneous Surgical Set with 5 mm or 10 mm Attachments K110431 Classification Order Decision Summary
STRATIFY JCV Antibody ELISA K112394 Classification Order Decision Summary
Neuropsychiatric EEG-Based Assessment Aid for ADHD (NEBA) System K112711 Classification Order Decision Summary
Proteus Personal Monitor Including Ingestion Event Marker K113070 Classification Order Decision Summary
PORTRAIT TOXIGENIC C. DIFFICILE ASSAY K113358 Classification Order Decision Summary
Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP) K113450 Classification Order Decision Summary
COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay K121291 Classification Order Decision Summary
xTAG® Gastrointestinal Pathogen Panel (GPP) K121454 Classification Order Decision Summary
Quantitation of Organophosphate Metabolites in Urine by LC/MS/MS K122282 Classification Order Decision Summary
Cefaly - Transcutaneous Electrical Nerve Stimulator K122566 Classification Order Decision Summary
AXIOS Stent and Delivery System K123250 Classification Order Decision Summary
X-ray Attenuating Cream K123422 Classification Order Decision Summary
PillCam® COLON 2 Capsule Endoscopy System K123666 Classification Order Decision Summary
Vysis EGR1 FISH Probe Kit K123951 Classification Order Decision Summary
Illumina MiSeqDx Platform K123989 Classification Order Decision Summary
FerriScan R2-MRI Analysis System K124065 Classification Order Decision Summary
VITEK®MS K124067 Classification Order Decision Summary
Pixel 3 System K130190 Classification Order Decision Summary
XSTAT K130218 Classification Order Decision Summary
CytoScan® Dx Assay K130313 Classification Order Decision Summary
Cerena Transcranial Magnetic Stimulator K130556 Classification Order Decision Summary
NeoTract UroLift System, Model REF UL400 K130651 Classification Order Decision Summary
Xpert MTB/RIF Assay K131706 Classification Order Decision Summary
Prostate Immobilizer Rectal Balloon K132194 Classification Order Decision Summary
EUROIMMUN Anti-PLA2R IFA K132379 Classification Order Decision Summary
IOGYN System K132695 Classification Order Decision Summary
MiSeqDx Universal Kit 1.0 K133136 Classification Order Decision Summary
Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Classification Order Decision Summary
Simplexa™ HSV 1 & 2 Direct K133621 Classification Order Decision Summary
Lyra Direct Strep Assay K133883 Classification Order Decision Summary

Page Last Updated: 08/11/2014
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