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.
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