NeoMed has a long history of innovative product design and commitment to patient safety and favorable outcomes. Our low dose syringe solution is certainly consistent with those objectives. GEDSA’s February 2016 Statement supported NeoMed’s low-dose solution, stating:
"A technical team of industry experts have worked collaboratively to identify a solution to address dose accuracy with a new ENFit low dose tip design. This design has been validated demonstrating the ability to deliver an accurate dose consistent with current practice with 95% confidence, fits appropriately into current practice and maintains compatibility with other ENFit devices. The ENFit low dose tip syringe is anticipated to be ready for market introduction in 2016 pending regulatory clearance."
We have offered our design to all syringe manufacturers in a royalty-free license arrangement, as well to the ISO working groups for inclusion into upcoming standard revisions at their discretion. In addition, we have supported the GEDSA timelines and have worked tirelessly with all manufacturers within GEDSA to facilitate a smooth transition across all patient populations.
NeoMed received 510(k) clearance for our current NeoConnect Enteral Syringes with ENFit connector (K143344) on April 8, 2015. NeoMed is currently one of only two enteral syringe manufacturers that have received FDA 510(K) clearance for enteral syringes with ENFit connectors.
Although NeoMed has been prepared to launch our ENFit product family for several months, we have continued to follow the delayed timelines issued by both GEDSA and other manufacturers, recognizing that we cannot ask facilities to transition until all of the devices used by our patient populations have ENFit versions. FDA has been very involved in many of the dialogs and has requested that usability and technical studies being sponsored by GEDSA be completed in advance of any device release. All of that work is scheduled to complete within the next 60 days and all results so far are completely consistent with our internal findings.
All syringe manufacturers are now expected to file new FDA 510(k)s specific to their low dose syringes.
We currently have the production capacity to support all of our customers as they move to ENFit and we anticipate being able to ship products to our customers according to their transition plans as early as June 2016 upon 510(k) clearance of the low dose syringe. Please feel free to reach out to NeoMed for additional information.
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