What the Government Shutdown Means to the Med Device Industry?

by | Jan 9, 2019 | FDA, Medical Devices, Shutdown

On December 22nd, 2018, the Federal Government went into a partial shutdown. Forty one percent of the FDA staff has been furloughed, which means that out of 17,397 FDA staff members, only 10,344 members have been retained for work.1 The number of furloughed employees may increase as the shutdown progresses. While these numbers are very horrifying and make us question the state of public health in the country, the actual impact is even more hard-hitting.

What remains unaffected by the shutdown:

FDA will continue to respond to emergencies such as high-risk medical device recalls, screening of imported medical devices entering the US, continue surveillance for adverse events and conduct criminal investigations when public health is greatly at risk.

The FDA will also carry over the user fee balances from 2018 and continue to review the pre-market applications whose user fees have been received prior to December 22nd, 2018; however, the review clock for these applications has been greatly impacted.2

FDA activities affected by the shutdown:

All routine medical device facility inspections have been halted along with all the research activities. FDA cannot accept any new pre-market applications that require a user fee, which means all those companies who planned on submitting a 510(k), PMA or any other premarket application in 2019 will have to wait until the shutdown has ended.2

The shutdown has not only affected the public health that FDA is committed to protecting but has also impacted the personal lives of the federal employees. Weston Szymanski, a consumer safety officer in the FDA’s Stoneham, Massachusetts office said: “The real victims are the American consumer and federal government employees.” 3 Some FDA employees have also taken to work without the assurance of a paycheck. FDA Commissioner, Dr. Scott Gottlieb, stated that, “Wherever we can, we will look at the safety mission first and foremost, but you know what will happen is that more of the routine work and more of the day-to-day review work will slow down, a lot of it slowed down already.” 3

We are closely monitoring the situation in D.C. and will keep you updated on how it will further impact the medical device industry.

If you have any questions or concerns, please call us at (248) 987- 4497 or email at info@emmainternational.com.

1 Department of Health and Human Services (Dec 2018) Fiscal Year 2019 Contingency Staffing Plan retrieved on 01-08-2019 from https://www.hhs.gov/sites/default/files/fy-2019-hhs-lapse-contingency-plan-narrative-december-ag-interior.pdf

2 FDA (Dec 2018) FDA 2018 Lapse in Funding Information retrieved on 01-08-2019 from https://www.fda.gov/AboutFDA/WorkingatFDA/ucm629100.htm?mkt_tok=eyJpIjoiT0dObVpUZGxZbVJrT1dGaSIsInQiOiJZZUIzNWpQK2dwRVlRcG11VmMydDg3K0M0b2t2Szg5QUV5bms0V3NwQmxXenRnQ21yekRuNDFoTHppekx0SXFLaDBmbHBGTmhnZ1FvdFdnVFkrREN2dmY1a2YrcndlN0Y5R0RUdStSMGxxSTJHNHppazduNTlkTXVtNmExcUhldCJ9

3 CNN (Jan 2019) FDA employees think shutdown could be deadly retrieved on 01-09-2019 from https://www.cnn.com/2019/01/08/health/fda-employee-concerns-shutdown/index.html

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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