When you think “510k” but FDA says “DeNovo” with Spencer Jones
This episode will explain to you the journey of the company Lineus Medical when they tried to register their products in the USA. Initially, they prepared the product to be registered with the 510k Regulatory Pathway but the FDA did not agree and said that they should go through DeNovo. So Spencer Jones who founded the company will tell us how they have done that and he will also give some tips on how he would have done it today if he had to restart again. So benefit from his journey to learn how you should do it.
Who is Spencer Jones?
Spencer worked for three years in direct patient care as a Certified Nursing Assistant, Licensed Practical Nurse, and as a Registered Nurse. Frustrated with the inefficiencies plaguing the healthcare system, he was determined to improve the delivery of healthcare. While still working as a nurse in the clinical setting, Spencer identified opportunities where improvement was needed around IV complication prevention. This led to the creation of SafeBreak® Vascular and the founding of Lineus Medical in 2015. Spencer graduated from the University of Arkansas with a Bachelor in the Science of Nursing. Spencer is on the Fayetteville Innovation Council and was the Entrepreneur in Residence for the Hub X Life Sciences Accelerator for 2016. He has three issued U.S. patents and several others pending.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…
- Spencer Jones LinkedIn: https://www.linkedin.com/in/spencer-jones-5a008672/
- Lineus Website: https://www.lineusmed.com
- FDA DeNovo guidance: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request