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Trump Signs 2019 US Federal Funding Bill, Stopping Another FDA Shutdown; CDRH Sees $69M Boost

 
• By Sue Darcey

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.

Capitol House

President Trump signed into law Feb. 15 an appropriations bill to fully fund remaining government agencies that otherwise would have been left unfunded – including US FDA – throughout the balance of the 2019 fiscal year. Congress passed the measure on Feb. 14.

The president's signature means there will not be a second government shutdown this year.

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More from United States

FDA Blocks Some Olympus Endoscopes From Entering US

 
• By Brian Bossetta

After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.

Newborn Screening Tests Among FDA Classifications

 
• By Elizabeth Orr

The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.

Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?

 
• By Brian Bossetta

It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

More from North America

Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?

 
• By Brian Bossetta

It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

Tarver And Makary Emphasize Commitment To At-Home Healthcare Innovations In FDA Podcast

 
• By Elizabeth Orr

FDA officials Michelle Tarver and Marty Makary discussed advancements in home healthcare during a podcast. They highlighted the importance of continuous glucose monitors, emphasized home healthcare's benefits for chronic diseases, and mentioned the agency's efforts to streamline device development.