Freyr provides FDA De-Novo Submission Services for medical device manufacturers that span across understanding De-Novo classification request and guiding throughout the classification process to obtain FDA clearance for novel devices.
Freyr has been a trusted partner for the FDA De-Novo submission services. Our team of experienced consultants specializes in understanding your FDA De-Novo classification request and guiding you through the De-Novo classification process in order to obtain FDA clearance for novel medical devices.