Tag: medical devices

… a major change to the Regulation is needed to prevent shortages of life-saving medical devices… Background On Friday 9 ...

The legislation previously introduced as the Pre-Approval Information Exchange Act of 2022 (“PIE Act”) was passed as part of Congress’s December 23, ...

When it comes to discussing medical devices regulated by the U.S. Food and Drug Administration (FDA), words such as “approved” ...

On September 28, 2022, the U.S. Food and Drug Administration (“FDA” or “the Agency”) issued its long-awaited final guidance, “Clinical ...

FDA Announces Total Product Life Cycle Advisory Program (TAP) Pilot - Life Sciences Perspectives FDA Announces Total Product Life Cycle ...