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 NameDEN#Classification OrderDecision Summary
Infrascanner Model 1000DEN100002Classification OrderDecision Summary
Zeltiq™ Dermal Cooling DeviceDEN090002Classification Order 
AirPurge SystemDEN080009Classification OrderDecision Summary
Bio-Seal Lung Biopsy Tract Plug SystemDEN090007Classification OrderDecision Summary
Erchonia ML ScannerDEN090008Classification Order 
NuMED NuCLEUS and NuCLEUS-X BAV CathetersDEN080015Classification OrderDecision Summary
Hem-Avert Perianal StabilizerDEN090011Classification Order 
ViruLite Cold Sore MachineDEN090012Classification OrderDecision Summary
RIDASCREEN Norovirus 3rd Generation EIADEN110001Classification Order 
Prostate Mechanical ImagerDEN100016Classification OrderDecision Summary
LipiFlow Thermal Pulsation SystemDEN100017Classification OrderDecision Summary
Steris Verify Spore Test Strip for S40DEN110002Classification OrderDecision Summary
InBios DENV Detect IgM Capture ELISADEN100020Classification OrderDecision Summary
AHIP Internal Trigger Point WandDEN100023Classification OrderDecision Summary
Cabochon SystemDEN110004Classification OrderDecision Summary
Widex C4-PA Wireless Air-Conduction Hearing AidDEN100025Classification OrderDecision Summary
Aptus Endovascular Suturing SystemDEN100026Classification OrderDecision Summary
Restiffic™ Restless Leg Relaxer Foot WrapDEN110009Classification OrderDecision Summary
Symphony Device (Models 09-0002-01, 09-0003-01, and 09-0004-01)DEN110011Classification OrderDecision Summary
ImmunoCAP TryptaseDEN120001Classification OrderDecision Summary
Percutaneous Surgical Set with 5 mm or 10 mm AttachmentsDEN110016Classification OrderDecision Summary
STRATIFY JCV Antibody ELISADEN120008Classification OrderDecision Summary
Neuropsychiatric EEG-Based Assessment Aid for ADHD (NEBA) SystemDEN110019Classification OrderDecision Summary
Proteus Personal Monitor Including Ingestion Event MarkerDEN120011Classification OrderDecision Summary
PORTRAIT TOXIGENIC C. DIFFICILE ASSAYDEN120013Classification OrderDecision Summary
Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP)DEN120014Classification OrderDecision Summary
COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assayDEN130002Classification OrderDecision Summary
xTAG® Gastrointestinal Pathogen Panel (GPP)DEN130003Classification OrderDecision Summary
Quantitation of Organophosphate Metabolites in Urine by LC/MS/MSDEN130005Classification OrderDecision Summary
Cefaly - Transcutaneous Electrical Nerve StimulatorDEN120019Classification OrderDecision Summary
AXIOS Stent and Delivery SystemDEN130007Classification OrderDecision Summary
X-ray Attenuating CreamDEN120022Classification OrderDecision Summary
PillCam® COLON 2 Capsule Endoscopy SystemDEN120023Classification OrderDecision Summary
Vysis EGR1 FISH Probe KitDEN130010Classification OrderDecision Summary
Illumina MiSeqDx PlatformDEN130011Classification OrderDecision Summary
FerriScan R2-MRI Analysis SystemDEN130012Classification OrderDecision Summary
VITEK®MSDEN130013Classification OrderDecision Summary
NEPHROCHECK® Test SystemDEN130031Classification OrderDecision Summary
Pixel 3 SystemDEN130015Classification OrderDecision Summary
XSTATDEN130016Classification OrderDecision Summary
CytoScan® Dx AssayDEN130018Classification OrderDecision Summary
Cerena Transcranial Magnetic StimulatorDEN130022Classification OrderDecision Summary
NeoTract UroLift System, Model REF UL400DEN130023Classification OrderDecision Summary
Xpert MTB/RIF AssayDEN130032Classification OrderDecision Summary
ReWalk™DEN130034Classification OrderDecision Summary
Prostate Immobilizer Rectal BalloonDEN130036Classification OrderDecision Summary
EUROIMMUN Anti-PLA2R IFADEN140002Classification OrderDecision Summary
IOGYN SystemDEN130040Classification OrderDecision Summary
MiSeqDx Universal Kit 1.0DEN130042Classification OrderDecision Summary
Lyra™ Direct HSV 1 + 2/VZV AssayDEN140004Classification OrderDecision Summary
Simplexa™ HSV 1 & 2 DirectDEN130049Classification OrderDecision Summary
Lyra Direct Strep AssayDEN140005Classification OrderDecision Summary
STUDIO on the Cloud Data Management SoftwareDEN140016Classification OrderDecision Summary
KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA AssayDEN140001Classification OrderDecision Summary

 

Page Last Updated: 10/28/2014
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