Advanced Medical Isotope has received a response from the US Food and Drug Administration (FDA) to its pre-market notification to the FDA pursuant to Section 510(k) of the US Food, Drug and Cosmetic Act for its Yttrium-90 (Y-90) RadioGel patented brachytherapy cancer product.
The FDA, which previously advised AMIC that it would review the product as a medical device, has further advised AMIC that it has determined that the product is classified by statute as a Class III medical device, unless the device is reclassified.
AMIC intends to work with the FDA to seek such reclassification, unless the additional steps required for approval of this product as a Class III medical device are more efficient. The company has obtained input from the FDA regarding its alternatives and will seek further input to expedite the process.
The company intends to shortly file for FDA clearance or approval for one related Yttrium-90 brachytherapy device and after receipt of substantive responses from the FDA to that application, file for clearance or approval for a third product.
Following notification of FDA clearance or approval, the company would immediately have the right to commence manufacturing, marketing and sales of the product in the US and its possessions. Subject to the receipt of additional funding, the Company also intends to begin the regulatory approval process outside of the US.
In the US, the company intends to outsource material aspects of manufacturing, distribution, sales and marketing. AMIC also intends to seek opportunities to license its products for worldwide sales, subject to the applicable local regulatory approvals.