De Novo classification scheme implemented by the US FDA 2020 agenda
The US FDA has included revised quality standards in their Spring 2020 Agency Rule List in order to align with ISO 13485:2016.
The FDA has initially proposed to revise the Quality System Regulations (QSR) as to provide simpler medical device market pathways in order to obtain 510(K) premarket notification, Premarket Approval (PMA) or other registration. Secondly, the FDA is proposing a more transparent process and it is expected to have a final De Novo classification rule for novel and cutting-edge devices by September 2020. These new rules, as stated by the FDA, are expected to generate benefits as cost-saving when reviewing De Novo requests.