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FDA Clearance Required for Low Dose Syringes

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."

Global Enteral Device Supplier Association (GEDSA). Guidance on Adoption of ISO 80369-3 Standard ENFit™ Connectors in California. February 2016.

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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