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Gottlieb Wants To 'Bring Medtech Manufacturing Home' In 2019 Budget Request

 
• By Sue Darcey

US FDA would use a proposed $128m, 39% budget authority increase in 2019 Center for Devices funding over the prior year to promote domestic device manufacturing, and let low-risk digital health products receive streamlined approvals, among other budget priorities, says FDA Commissioner Scott Gottlieb.

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• Source: shutterstock.com

The Trump administration has proposed increasing FDA's device center's spending to about $636m in FY 2019, a 26% increase over the $505m allotted for 2018.

Budget authority for devices would rise from $327m to $455m in 2019 under the proposal. The $636m, 2019 total would include $180m in medical device user fees, about $2

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Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.