How Is the Government Shutdown Impacting Medtech?

If you think medical device companies are not impacted by the U.S. federal shutdown, think again. FDA commissioner Scott Gottlieb, MD, took to Twitter this week to highlight agency employees who are working unpaid to perform mission-critical activities. FDA cannot legally accept any new medical device or drug submissions until the government shutdown ends because the user fees that are collected with these submissions cannot be processed during the lapse period. The agency is able to support activities funded by carryover user fee balances from FY 2018, but medical device user fee programs only have about two months to three months left, and pharmaceutical user fee programs have less than that. The agency said it is continuing vital activities that are considered critical to ensuring public health and safety in the United States. These activities include: maintaining core functions to handle and respond to emergencies; supporting high-risk food and medical product recalls; pursuing civil investigations when public health is believed to be imminently at risk and pursuing criminal investigations; screening food and medical products imported to the country; and surveillance for significant safety concerns with medical devices and other medical products. "You’re valued each day," Gottlieb Tweeted to FDA staff. "But it’s even more the case that in moments of challenge, when ...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news