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FDA Proposes Major Changes to De Novo Pathway
De Novo classification, also known as Evaluation of Automatic Class III Designation, is a risk-based classification process of novel devices for which there are no legally marketed predicate devices. Under this...
FDA to Overhaul 510(k) Device Approval Process
Established in 1976, a 510(k) is a “premarket submission made to FDA [by medical device manufacturers] to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially...