The medicines Food and Drug Administration ( FDA ) has proposed a change to regulations regarding medical devices , as it seeks to keep up with the ever - expanding market for these products . The De Novo bio Proposed Rule aims to update the existing medical device 510(k ) clearance requirements . It will introduce procedures and criteria for the De Novo classification process , and bring in a 120-day review period for classification requests . In addition to steep fees and performance goals for these requests , the FDA wants to allow the market to continue expanding , while ensuring a safe environment for users .
The US Food and Drug Administration (FDA) has proposed a change to regulations regarding medical devices, as it seeks to keep up with the ever-expanding market for these products. The De Novo Classification Proposed Rule aims to update the existing medical device 510(k) clearance pathway. It would introduce procedures and criteria for the De Novo classification process, and bring in a 120-day review period for classification requests. In addition to steep fees and performance goals for these requests, the FDA wants to allow the market to continue developing, while ensuring a safe environment for users.