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Study Shows Extended FDA Clearance Time for Medical Devices

FDA device clearance times remain lengthy—averaging 140–175 days, far beyond the 90-day goal. Staffing cuts and process shifts fuel delays, while underused third-party review programs offer a potential shortcut for manufacturers seeking faster approvals.

FDA to Expand Use of AI in Scientific Reviews

The use of artificial intelligence (AI) tools is rapidly gaining traction throughout industries around the world. Now, the U.S. Food and Drug Administration (FDA) is stepping up to leverage the potential benefits of AI.

FDA Struggles to Meet Product Review Deadlines

Staff at the U.S. Food and Drug Administration (FDA) are reportedly struggling to meet application review deadlines for medical device and tobacco products due to recent staff reductions.

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