Trump Signs 2019 US Federal Funding Bill, Stopping Another FDA Shutdown; CDRH Sees $69M Boost
US FDA’s device center gained a total of $471.4m in budget authority, plus more than $200m that Congress authorized in user-fee funding for the current fiscal year, in a 2019 federal agency spending package signed into law Feb. 15 by the president that prevented a second agency shutdown. The $471.4m budget is roughly $69m more than was given to CDRH for FY 2018.
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FDA Will Have To Scrape By On Continuing Resolution Funding Through December, Legislative Experts Predict
While a government agency shutdown due to lack of agreement between Congress and the Trump administration over funding for the US Food and Drug Administration and other federal agencies seems less likely this year than last, the FDA will still have carry out its 2020 mission in the short term on 2019 continuing resolution funding – probably through December – legislative experts say.
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.