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Significant progress made with recent recommendation by EU Notified Body 1 for approval of MED3000 as a breakthrough, fast acting, clinically proven treatment for erectile dysfunction: In February 2020 formal proceedings commenced for approval as a medical device available throughout EU without the need of a doctor s prescription ( OTC ). In July 2020, Futura submitted the Technical Dossier for MED3000 for marketing approval. In August 2020 positive audit opinion received for Futura s Quality Management Systems ( QMS ). EU certificate expected before the end of May 2021 under Medical Device Regulation.
De Novo medical device status for MED3000 confirmed by US Food and Drug Administration ( FDA ) in February 2020 pre-submission meeting. ....