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 1000K080377Approval LetterDecision Summary
Zeltiq™ Dermal Cooling DeviceK080521Approval Letter 
AirPurge SystemK080644 Decision Summary
Bio-Seal Lung Biopsy Tract Plug SystemK082438Approval LetterDecision Summary
Erchonia ML ScannerK082609Approval Letter 
NuMED NuCLEUS and NuCLEUS-X BAV CathetersK082776Approval LetterDecision Summary
Hem-Avert Perianal StabilizerK083692Approval Letter 
ViruLite Cold Sore MachineK083767Approval LetterDecision Summary
RIDASCREEN Norovirus 3rd Generation EIAK093295Approval Letter 
Prostate Mechanical ImagerK093579Approval LetterDecision Summary
LipiFlow Thermal Pulsation SystemK093937Approval LetterDecision Summary
Steris Verify Spore Test Strip for S40K100049Approval LetterDecision Summary
InBios DENV Detect IgM Capture ELISAK100534Approval LetterDecision Summary
AHIP Internal Trigger Point WandK100934Approval LetterDecision Summary
Cabochon SystemK101231Approval LetterDecision Summary
Widex C4-PA Wireless Air-Conduction Hearing AidK101699Approval LetterDecision Summary
Aptus Endovascular Suturing SystemK102333Approval LetterDecision Summary
Symphony Device (Models 09-0002-01, 09-0003-01, and 09-0004-01)K102873Approval LetterDecision Summary
ImmunoCAP TryptaseK103039Approval LetterDecision Summary
Percutaneous Surgical Set with 5 mm or 10 mm AttachmentsK110431Approval LetterDecision Summary
STRATIFY JCV Antibody ELISAK112394Approval LetterDecision Summary
Neuropsychiatric EEG-Based Assessment Aid for ADHD (NEBA) SystemK112711Approval LetterDecision Summary
Proteus Personal Monitor Including Ingestion Event MarkerK113070Approval LetterDecision Summary
PORTRAIT TOXIGENIC C. DIFFICILE ASSAYK113358Approval LetterDecision Summary
Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP)K113450Approval LetterDecision Summary
COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assayK121291Approval LetterDecision Summary
xTAG® Gastrointestinal Pathogen Panel (GPP)K121454Approval LetterDecision Summary
Quantitation of Organophosphate Metabolites in Urine by LC/MS/MSK122282Approval LetterDecision Summary
Cefaly - Transcutaneous Electrical Nerve StimulatorK122566Approval LetterDecision Summary
AXIOS Stent and Delivery SystemK123250Approval LetterDecision Summary
X-ray Attenuating CreamK123422Approval LetterDecision Summary
PillCam® COLON 2 Capsule Endoscopy SystemK123666Approval LetterDecision Summary
Vysis EGR1 FISH Probe KitK123951Approval LetterDecision Summary
Illumina MiSeqDx PlatformK123989Approval LetterDecision Summary
FerriScan R2-MRI Analysis SystemK124065Approval LetterDecision Summary
VITEK®MSK124067Approval LetterDecision Summary
Pixel 3 SystemK130190Approval LetterDecision Summary
XSTATK130218Approval LetterDecision Summary
CytoScan® Dx AssayK130313Approval LetterDecision Summary
Cerena Transcranial Magnetic StimulatorK130556Approval LetterDecision Summary
NeoTract UroLift System, Model REF UL400K130651Approval LetterDecision Summary
Xpert MTB/RIF AssayK131706Approval LetterDecision Summary
Prostate Immobilizer Rectal BalloonK132194Approval LetterDecision Summary
EUROIMMUN Anti-PLA2R IFAK132379Approval LetterDecision Summary
IOGYN SystemK132695Approval LetterDecision Summary
MiSeqDx Universal Kit 1.0K133136Approval LetterDecision Summary
Lyra™ Direct HSV 1 + 2/VZV AssayK133448Approval LetterDecision Summary
Simplexa™ HSV 1 & 2 DirectK133621Approval LetterDecision Summary
Lyra Direct Strep AssayK133883Approval LetterDecision Summary


Page Last Updated: 07/16/2014
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