Combination medical devices which bring together device components and drugs or biological products into a single unit are missing from new draft guidance from the FDA. The guidance, released last week, covered recommendations for manufacturers on when to submit 510(k) applications for modifications to devices currently on the market, replacing guidance that was 19 years […]
Food & Drug Administration (FDA)
Intersect ENT files with FDA for drug-delivering sinus implant
Intersect ENT (NSDQ:XENT) said today it submitted a supplemental premarket approval submission to the FDA seeking approval for a new Nova steroid releasing implant for treating patients with chronic sinus disease. The new Nova device is designed with a lower profile to allow for placement in smaller sinus openings, and will expand the usable patient population for […]
