FDA update January 18, 2012

Evaluation of Automatic Class III Designation (De Novo) Decision Summaries

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate.

  • The De Novo process applies to low and moderate risk devices that have been classified as class III because they were found not substantially equivalent (NSE) to existing devices.
  • Applicants who receive this determination may request a risk-based evaluation for reclassification into class I or II. Devices that receive this reclassification are considered to be approved through the De Novo process.
  • If a De Novo is approved, it may be used as a predicate for future Premarket Notification [510(k)] submissions.

As a pilot program under the CDRH Transparency Initiative, FDA has begun releasing the decision summary review memos for De Novo devices which can be found in the table below.

Device Name

510(k) Number

Infrascanner Model 1000/p>


Erchonia ML Scanner


Hem-Avert Perianal Stabilizer


Zeltiq™ Dermal Cooling Device


LipiFlow Thermal Pulsation System


Widex C4-PA Wireless Air-Conduction Hearing Aid


Aptus Endovascular Suturing System


Using the DeNovo is a new avenue for obtaining 510(k) clearance. If you have any questions on this process or on this FDA update please email us at info@mdiconsultants.com and Ref: De Novo Decision Summaries

For more information on Evaluation of Automatic Class III Designation   FDA has guidance on “New Section 513(f) (2) - Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff”


Or you can go to the following link: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm232269.htm?source=govdelivery .