Jan 3, 2019
EMERGO BY UL SUMMARY OF KEY POINTS:
A partial US government shutdown stemming from border wall and security disputes between President Donald Trump and Congress has hindered the Food and Drug Administration’s ability to accept and review medical device regulatory submissions.
A notice from FDA on government funding lapses that started in late 2018 states that the agency currently has no legal authority to collect user fees assessed for its 2019 fiscal year, which prevents the regulator from accepting new regulatory submissions such as 510(k)s and Premarket Applications (PMA) that require fees until Congress and the White House restore full funding. Medical device manufacturers planning to submit applications for US market authorization in early 2019 should factor these operational delays at FDA into their commercialization plans.
Although FDA may not currently accept new medical device registration applications, the agency continues carrying out the following medical device oversight-related functions:
Also, the agency will use carryover fee balances from 2018 to support commercialization of novel medical devices and technologies, according to the notice. Again, however, no submissions requiring 2019 fiscal year user fees will be accepted until full government funding is reestablished.
EMERGO BY UL SUMMARY OF KEY POINTS:
EMERGO BY UL SUMMARY OF KEY POINTS: