As US FDA Shutdown Continues, What Will Be The Cost Of Not Spending?
Bolus of applications could be filed once government reopens, but employee morale and recruitment efforts could suffer drop-off.
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US House lawmakers might pursue legislation in 2019 to repeal the device tax, ensure that FDA can continue working on medtech product reviews during US government shutdowns, and to stabilize the Affordable Care Act to lower health-care costs for patients.
Commissioner Scott Gottlieb tells Congress FDA won’t meet all its planned inspection goals after a month-long partial government shutdown, but he does not expect a noticeable impact on product reviews. Longer-term impacts will depend on morale: hiring and retention are focal points.
The recently ended record-setting US government shutdown is not anticipated to have a long-term impact on US FDA device review times. But agency reviewers will face more 510(k) review deadline pressures than usual and may have limited availability for pre-submission meetings in the short term, one expert suggests.