THE BAJA POST
SOURCE: PR MEDIA
Bioretec Ltd, a pioneer in bioresorbable orthopedic implants, has finalized the supplement for market authorization request in accordance with the De Novo registration process concerning the company’s RemeOs™ trauma screw, and FDA (U.S. Food and Drug Administration) has now confirmed having received the supplement. Bioretec’s estimate for receival of the U.S. market authorization remains unchanged in April 2023.
After receiving the supplement, FDA has, according to its internal guidelines, a maximum of 90 calendar days to finalize the decision.
Bioretec submitted the De Novo market authorization request for the RemeOs™ trauma screw to the FDA in May 2022. The De Novo request process is used when similar products do not yet have market authorization in the United States.
“Our work on this approval process is nearing completion, and we await the FDA’s decision-making process and obtaining market authorization for the RemeOs™ trauma screw during April,” says Timo Lehtonen, CEO of Bioretec.