Advanced Medical Isotope (AMIC) has filed a de novo submission with the US Food and Drug Administration (FDA) for marketing approval of its patented Y-90 RadioGel device.
FDA rejected the firm’s request for marketing approval for the same device under Section 510(k) of the US Food, Drug and Cosmetic Act in February 2014.
The company is seeking reclassification of the product to Class II, by filing the de novo submission.
AMIC plans to explore steps toward seeking approval for the device as a Class III medical device, if the de novo submission is declined.
The company noted that it would immediately market the device in the US, if the submission is granted.
AMIC is a late stage development company that develops brachytherapy devices and medical isotopes for diagnostic and therapeutic applications.