From what I understand Biel submitted two 510k's for FDA approval on Feb 12th. Several weeks ago FDA contacted Biel for more product info. Apparently this is supposed to be a fast tract deal so 90 days would be May 12. But who knows for sure what FDA will do or need more for final approval. Have to be patient. In mean time Actipatch finding their way to CVS shelves and worldwide acceptance growing. Patience is prudence at this moment.