| Evaluation of Automatic Class III Designation (De Novo) Decision : K093295 added |
| Scritto da CDRH New |
 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.Fonte: CDRH New |