Advertisement
News
Advertisement

Evaluation of Automatic Class III Designation (De Novo) Summaries (K123250 letter added)

Thu, 01/09/2014 - 12:00am
U.S. Food & Drug Administration

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 Name510(k) NumberApproval LetterDecision Summary
Infrascanner Model 1000 K080377 Approval Letter Decision Summary
Zeltiq™ Dermal Cooling Device K080521 Approval Letter  
Bio-Seal Lung Biopsy Tract Plug System K082438 Approval Letter Decision Summary
Erchonia ML Scanner K082609 Approval Letter  
NuMED NuCLEUS and NuCLEUS-X BAV Catheters K082776 Approval Letter Decision Summary
Hem-Avert Perianal Stabilizer K083692 Approval Letter  
ViruLite Cold Sore Machine K083767 Approval Letter Decision Summary
RIDASCREEN Norovirus 3rd Generation EIA K093295 Approval Letter  
Prostate Mechanical Imager K093579 Approval Letter Decision Summary
LipiFlow Thermal Pulsation System K093937 Approval Letter Decision Summary
Steris Verify Spore Test Strip for S40 K100049 Approval Letter Decision Summary
InBios DENV Detect IgM Capture ELISA K100534 Approval Letter Decision Summary
Cabochon System K101231 Approval Letter Decision Summary
Widex C4-PA Wireless Air-Conduction Hearing Aid K101699 Approval Letter Decision Summary
Aptus Endovascular Suturing System K102333 Approval Letter Decision Summary
ImmunoCAP Tryptase K103039 Approval Letter Decision Summary
Percutaneous Surgical Set with 5 mm or 10 mm Attachments K110431 Approval Letter Decision Summary
STRATIFY JCV Antibody ELISA K112394 Approval Letter Decision Summary
Neuropsychiatric EEG-Based Assessment Aid for ADHD (NEBA) System K112711 Approval Letter Decision Summary
Proteus Personal Monitor Including Ingestion Event Marker K113070 Approval Letter Decision Summary
PORTRAIT TOXIGENIC C. DIFFICILE ASSAY K113358 Approval Letter Decision Summary
Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP) K113450 Approval Letter Decision Summary
COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay K121291 Approval Letter Decision Summary
xTAG® Gastrointestinal Pathogen Panel (GPP) K121454 Approval Letter Decision Summary
Quantitation of Organophosphate Metabolites in Urine by LC/MS/MS K122282 Approval Letter Decision Summary
AXIOS Stent and Delivery System K123250 Approval Letter  
X-ray Attenuating Cream K123422 Approval Letter Decision Summary
Vysis EGR1 FISH Probe Kit K123951 Approval Letter Decision Summary
Illumina MiSeqDx Platform K123989 Approval Letter Decision Summary
FerriScan R2-MRI Analysis System K124065 Approval Letter Decision Summary
VITEK®MS K124067 Approval Letter Decision Summary
NeoTract UroLift System, Model REF UL400 K130651 Approval Letter Decision Summary
Xpert MTB/RIF Assay K131706 Approval Letter Decision Summary
MiSeqDx Universal Kit 1.0 K133136 Approval Letter Decision Summary

Topics

Advertisement

Share this Story

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading