FDA update – May 2, 2011

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.

Below is the list of the medical devices that are reclassified from class III to class II according to De Novo classification:

For more information on De Novo summaries you can go to the following link:http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm232269.htm or contact mdi at info@mdiconsultants.com REF: De Novo Summaries.