About FDA

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 NameFile NumberClassification OrderDecision Summary
Infrascanner Model 1000K080377Classification OrderDecision Summary
Zeltiq™ Dermal Cooling DeviceK080521Classification Order 
AirPurge SystemK080644Classification OrderDecision Summary
Bio-Seal Lung Biopsy Tract Plug SystemK082438Classification OrderDecision Summary
Erchonia ML ScannerK082609Classification Order 
NuMED NuCLEUS and NuCLEUS-X BAV CathetersK082776Classification OrderDecision Summary
Hem-Avert Perianal StabilizerK083692Classification Order 
ViruLite Cold Sore MachineK083767Classification OrderDecision Summary
RIDASCREEN Norovirus 3rd Generation EIAK093295Classification Order 
Prostate Mechanical ImagerK093579Classification OrderDecision Summary
LipiFlow Thermal Pulsation SystemK093937Classification OrderDecision Summary
Steris Verify Spore Test Strip for S40K100049Classification OrderDecision Summary
InBios DENV Detect IgM Capture ELISAK100534Classification OrderDecision Summary
AHIP Internal Trigger Point WandK100934Classification OrderDecision Summary
Cabochon SystemK101231Classification OrderDecision Summary
Widex C4-PA Wireless Air-Conduction Hearing AidK101699Classification OrderDecision Summary
Aptus Endovascular Suturing SystemK102333Classification OrderDecision Summary
Restiffic™ Restless Leg Relaxer Foot WrapK102707Classification OrderDecision Summary
Symphony Device (Models 09-0002-01, 09-0003-01, and 09-0004-01)K102873Classification OrderDecision Summary
ImmunoCAP TryptaseK103039Classification OrderDecision Summary
Percutaneous Surgical Set with 5 mm or 10 mm AttachmentsK110431Classification OrderDecision Summary
STRATIFY JCV Antibody ELISAK112394Classification OrderDecision Summary
Neuropsychiatric EEG-Based Assessment Aid for ADHD (NEBA) SystemK112711Classification OrderDecision Summary
Proteus Personal Monitor Including Ingestion Event MarkerK113070Classification OrderDecision Summary
PORTRAIT TOXIGENIC C. DIFFICILE ASSAYK113358Classification OrderDecision Summary
Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP)K113450Classification OrderDecision Summary
COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assayK121291Classification OrderDecision Summary
xTAG® Gastrointestinal Pathogen Panel (GPP)K121454Classification OrderDecision Summary
Quantitation of Organophosphate Metabolites in Urine by LC/MS/MSK122282Classification OrderDecision Summary
Cefaly - Transcutaneous Electrical Nerve StimulatorK122566Classification OrderDecision Summary
AXIOS Stent and Delivery SystemK123250Classification OrderDecision Summary
X-ray Attenuating CreamK123422Classification OrderDecision Summary
PillCam® COLON 2 Capsule Endoscopy SystemK123666Classification OrderDecision Summary
Vysis EGR1 FISH Probe KitK123951Classification OrderDecision Summary
Illumina MiSeqDx PlatformK123989Classification OrderDecision Summary
FerriScan R2-MRI Analysis SystemK124065Classification OrderDecision Summary
VITEK®MSK124067Classification OrderDecision Summary
NEPHROCHECK® Test SystemK130031Classification OrderDecision Summary
Pixel 3 SystemK130190Classification OrderDecision Summary
XSTATK130218Classification OrderDecision Summary
CytoScan® Dx AssayK130313Classification OrderDecision Summary
Cerena Transcranial Magnetic StimulatorK130556Classification OrderDecision Summary
NeoTract UroLift System, Model REF UL400K130651Classification OrderDecision Summary
Xpert MTB/RIF AssayK131706Classification OrderDecision Summary
ReWalk™K131798Classification OrderDecision Summary
Prostate Immobilizer Rectal BalloonK132194Classification OrderDecision Summary
EUROIMMUN Anti-PLA2R IFAK132379Classification OrderDecision Summary
IOGYN SystemK132695Classification OrderDecision Summary
MiSeqDx Universal Kit 1.0K133136Classification OrderDecision Summary
Lyra™ Direct HSV 1 + 2/VZV AssayK133448Classification OrderDecision Summary
Simplexa™ HSV 1 & 2 DirectK133621Classification OrderDecision Summary
Lyra Direct Strep AssayK133883Classification OrderDecision Summary
STUDIO on the Cloud Data Management SoftwareK140016Classification OrderDecision Summary


Page Last Updated: 10/16/2014
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