U Deliver Medical, LLC announced they have received Food and Drug Administration (FDA) 510(k) regulatory clearance for The bFed™ System tube feeding delivery products (Bolink™ tubing), to now be available to consumers without a prescription. This makes the bFed System the first tube feeding delivery system to be available without a prescription.
Launched in February 2018, The bFed System is an innovative tube feeding delivery system that makes it easier for home tube feeders to deliver any form of nutrition they choose. “Home tube feeders and their caregivers face enough obstacles in daily life without having additional restrictions when choosing options for getting the nutrition they need,” said Brian Johnson, president and co-founder of U Deliver Medical. “Requiring a prescription was an additional burden resulting in more contacts with healthcare providers for a person that already has a feeding tube and can’t eat by mouth,” added Fred Reuning, vice-president and co-founder of U Deliver Medical. “We created The bFed System specifically to help make tube feeding a little easier, so we are extremely pleased that it is now more readily available.”
Vista Regulatory Solutions, LLC (www.vistareg.com) led the development of the regulatory strategy and managed the submission process with the FDA. “It was a pleasure to work with U Deliver Medical in developing their regulatory strategy for the Bolink products. These products were a natural fit for over-the-counter use as was evident by the usability testing that showed they could be used safely without direction from a health care professional,” said Tom Dold, president, Vista Regulatory Solutions.
About U Deliver Medical
Founded in 2016, U Deliver Medical LLC is dedicated to providing home tube feeders with nutrition delivery products that give them the freedom to choose how to deliver the nutrition they need when they want it and where they want it. Nutrition is vital to improved health and healing, and tube feeding delivery needs to evolve to eliminate barriers for proper nutrition to be achieved.
SOURCE U Deliver Medical