FDA Roundup: June 13, 2023 wtva.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from wtva.com Daily Mail and Mail on Sunday newspapers.
/PRNewswire/ Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the.
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.