The FDA is not accepting new medical device registration applications funded by user fees during the ongoing partial federal government shutdown. The medtech industry hasn’t been complaining about it yet, but time will tell, according to some experts.
Applications for devices covered by the agency’s 510(k) and Premarket Approval (PMA) processes accepted before Dec. 22 will continue to be processed, the FDA said, but it cannot accept any new fees until Congress and President Trump restore full funding for fiscal year 2019. User fees accounted for $5.4 billion or about 45% of FDA’s total budget for 2018.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.