How the Government Shutdown Affects Medical Devices

By MedTech Intelligence Staff
January 7, 2019


• Categories: 03-Manufacturing Execution, 04-Product Design & Development, 05-Quality/Regulatory, Business Analysis, Market Access, RC - Medtech Regulatory Resource Center

As one of the longest U.S. government shutdowns in history continues, folks across industries are becoming more concerned about what resources will and will not be available. Medical device manufacturers can rest assured knowing that FDA will continue any “mission critical” activities, which includes supporting medical device recalls, screening device imports, pursuing any civil or criminal investigations that affect public health, and continuing important device surveillance. “The FDA will continue to support activities funded by carryover user fee balances, which allows us to continue to bring new therapeutic options to the patients that need them,” according to an FDA notice.

However, no user fees for 2019 will be collected and the agency cannot accept new medical device registration applications. As for whether or not FDA employees will be paid, the agency provided the following information on a FAQ page:

“All employees will get paid on December 28, 2018. Furloughed, excepted, and exempt employees will be paid for hours worked and leave used through December 21st, 2018. In addition, staff who are exempt and working directly on work funded by user fee carry over funding (or other funds not impacted by a lapse in appropriation) will be paid for all user fee work completed during the furlough.
Exempt employees working on user fee funded work (or other funds not impacted by a lapse in appropriation) will continue to be paid for that work. Such payment is expected to be processed on a bi-weekly basis for the duration of the shutdown. Excepted employees working during the shutdown will be paid for hours worked retroactively once a FY19 appropriation or Continuing Resolution is approved.” – FDA