Evaluation of Automatic Class III Designation (De Novo) Decision Summaries (Added K101699)
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. Links to all available decision summary review memos can be found in the table below.
|Device Name||510(k) Number|
|Erchonia ML Scanner||K082609||Approval Letter||Decision Summary|
|Hem-Avert Perianal Stabilizer||K083692||Approval Letter||Decision Summary|
|Zeltiq™ Dermal Cooling Device||K080521||Approval Letter||Decision Summary|
|C4-P4 Wireless Air-Conduction Hearing Aid||K101699||Approval Letter||Decision Summary|