Jan 3, 2019

EMERGO BY UL SUMMARY OF KEY POINTS:

  • A partial US government shutdown has resulted in the suspension of FDA’s authority to collect medical device application user fees for the 2019 fiscal year.
  • Inability to collect user fees means FDA cannot accept any new medical device registration applications that require such fees until full US government funding resumes.
  • FDA will continue to carry out oversight functions related primarily to high-risk medical devices, imported product screenings and novel therapies.

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.

No new 510(k) and other application reviews until funding resumes

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.

FDA activities unaffected by the shutdown

Although FDA may not currently accept new medical device registration applications, the agency continues carrying out the following medical device oversight-related functions:

  • Supporting high-risk medical device recall efforts;
  • Pursuing civil and criminal legal actions related to devices that threaten public health;
  • Screening devices imported from other countries;
  • Surveillance of devices for major safety issues;

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.

Related US FDA medical device regulatory information from Emergo by UL:

  • US FDA 510(k) consulting for medical device and IVD companies
  • US FDA medical device and IVD regulatory strategy
  • Whitepaper: Early communication with the US FDA

 

Author

  • Stewart Eisenhart

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