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GE HealthCare Preps for SIR 2024

GE HealthCare will showcase its latest technologies in image guiding solutions, surgery, ultrasound and CT-navigation at the upcoming 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting taking place March 23-28 in Salt Lake City, Utah. The...

Samsung Accepts Healthcare Innovator Award

Boston Imaging, the United States headquarters of Samsung’s digital radiography and ultrasound business, was awarded HHM Health’s Healthcare Innovator Award

AHRA Co-Founder Passes Away

On March 2, 2024, Louise Broadley passed away at 101 years old. AHRA shared the news via an email and website post that reads, “She was a noble woman, who not only achieved many milestones within the imaging profession, but likewise paved the way for aspiring leaders...

Artificial Intelligence Paper Outlines FDA’s Approach to Protect Public Health and Promote Ethical Innovation

Today, the U.S. Food and Drug Administration (FDA) released its “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” which outlines how FDA’s medical product centers are working together to protect public health while...

FDA Releases MDUFA Statement

The FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for the fifth reauthorization of the medical device user fee program. Under the new agreement, the FDA would be authorized to collect at least $1.78 billion in user fees over five years, plus additional funding, for a total of up to $1.9 billion to further improve performance if specified goals are met. This funding would provide critical resources to the FDA medical device review program. The proposed recommendations have been posted on our website and will be published in the Federal Register for public comment. Additionally, the MDUFA V public meeting will be held virtually April 19, 2022, to provide the public an opportunity to learn more about and provide their views on the proposed recommendations. The final recommendations are scheduled to be delivered to Congress in April 2022, after FDA considers public input on the proposed recommendations and revises them as necessary.

“The agreement underscores the continued commitment by the FDA and medical device industry to prioritize innovation and increase patient access to safe and effective medical devices,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “In addition, MDUFA V represents a substantial investment in the future of the agency’s medical device program and would provide for important improvements, including new hiring targets, greater engagement with developers of innovative technologies based on lessons learned from the pandemic, broadened international harmonization efforts and expanded opportunities to ensure patient perspectives are an integral part of medical device development.”

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