Is this Friday 13th going to be a lucky day for RAP holders?
By my calculations, it will be 150 days since FDA submission....
"The final step is the De Novo request decision. Under MDUFA IV, the FDA's goal is to make a decision about a De Novo request in 150 review days. Review days are calculated as the number of calendar days between the date the De Novo request was received by the FDA and the date of the FDA's decision, excluding the days a request was on hold for an Additional Information request."
"If your data and information demonstrate that general controls or general and special controls are adequate to provide reasonable assurance of safety and effectiveness, and the probable benefits of the device outweigh the probable risks, then the FDA intends to grant the De Novo request and establish a new classification regulation for a new device type."
