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Evaluation of Automatic Class III Designation (De Novo) Decision Summaries (Added K101699)

Fri, 04/29/2011 - 7:30am
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 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

 

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