Medical Device Forum discusses current FDA regulatory environment

NCBIO members got an overview of the Food and Drug Administration’s regulatory environment for medical devices both during the pandemic and now at the NCBIO Medical Device Forum held May 11 at the NC Biotechnology Center. 

Robert Rosenthal, a partner with MED1 Ventures, moderated a panel comprising 

• Roxy Kozyckyj, director of state government and regional affairs at AdvaMed; 
• Karl Nobert, senior counsel at Michael Best; and 
• Alessandra Pavesio, senior vice president and chief scientific officer at Bioventus. 

The event was made possible by sponsor Michael Best, a full-service law and consulting firm with offices in Raleigh and around the country and world. 

“COVID has changed everything over the past two years,” Kozyckyj said. 

FDA was understaffed before the COVID-19 pandemic, panelists said, and the added stress of the pandemic has not helped matters.  

“Certainly, the pandemic has been problematic for any company that was not doing anything that was COVID related,” Pavesio said. “I don't want to make it all negative. Definitely the FDA did some things for manufacturers. They granted, for example, an extra six months in providing answers to some of the questions, but the questions could have been avoided if there hadn't been all this change.” 

The pandemic radically changed the approval process at the FDA as the agency shifted resources and personnel to prioritize products and treatments targeting COVID. For manufacturers working in other areas, this shift has resulted in significant delays as the personnel they were originally working with were moved to new assignments, and their replacements had to be brought up to speed, Nobert and Pavesio said. 

For small companies trying to navigate the FDA approval process, the panelists said that making connections and building relationships within the agency is incredibly important.  

“Connections are the most important thing you can do with FDA,” Nobert said. “Don't get people angry, because the bridges that you build are incredibly valuable, [people] that will pick up the phone and give you directions to others.”