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The FDA has cleared Vonco Products’ EnteraLoc Flow as an over-the-counter (OTC) direct-connect feeding solution for enteral patients, allowing enterally fed individuals and their caregivers to purchase it without a prescription. EnteraLoc Flow was granted 510(k) clearance (Rx Only) by the FDA in 2021. (The EnteraLoc™ enteral device won the Flexible Packaging Association’s 2022 Highest Achievement Award, as well as four Gold Awards in Packaging Excellence, Sustainability, Technical Innovation, and Expanding the Use of Flexible Packaging.)
To earn the OTC designation, Vonco offered Human Factors study data that overwhelmingly demonstrated that the EnteraLoc Flow feeding system is safe and effective and that the instructions were clear enough to facilitate proper use by the average person.
The company estimates the OTC version will be available via online retail by late 2023. In the meantime, the product will remain in readily available supply through current access channels.
“We’re very pleased with the FDA’s decision,” says Keith Smith, CEO of Vonco Products. “EnteraLoc Flow is designed to improve the nutrition of enteral patients by providing a convenient method of food delivery that is simple, safe, reduces mess, and can be consumed on the go. Designating EnteraLoc Flow as an OTC solution will help physicians and caregivers deliver better enteral care.”
“Proper nutrition can be lifesaving to enteral patients,” adds David Marks, president and CEO of Medtrition, an international supplier of medical foods. “Being able to administer enteral nutrition quickly and safely with just a squeeze of a pouch equipped with the EnteraLoc Flow direct-connect ENFit® device reinvents enteral tube feeding. As a valued partner of Vonco, we look forward to expanding our enteral offering to include the EnteraLoc Flow OTC feeding system. When combined with nutritious formulations, I believe there is no better feeding solution for the home enteral community.”
