How the Government Shutdown Affects Medical Devices

By MedTech Intelligence Staff

Mission critical activities, such as device recalls and surveillance related to product safety concerns will continue.

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

Related Articles

  • Hand holding globe - diversity

    “Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities” offers key recommendations for device manufacturers and developers on steps they can take to increase diversity in clinical research and address health equity.

  • RQM plus logo

    Jordi labs and its team of Ph.D. analytical chemists developed a proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements.

  • Pixabay Globe

    The increase in global regulatory demands for medical devices has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory professionals, device developers and regulators to look at current…

  • ISO_13485

    Device manufacturers and importers will have two years to modify their Quality Systems to meet the requirements of the QMSR rule by February 2, 2026.

About The Author

MedTech Intelligence