@Srg36 did a great job of summarizing the de Novo classification process and ruling. I agree that this deNovo classification process is beneficial because previously having an automatic Class III determination and to submit to have down classed to Class I or II is inefficient. Having the deNovo process is both time and money saving for both the FDA and company submitting. It’s also helpful that the class I or class II through the de novo process may be marketed and used as predicates for future premarket notifications. This way manufacturers can look at the de novo decisionsummary as a resource with the information necessary to support substantial equivalence for devices that they may wish to use the device as a predicate.