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October 5, 2023
The U.S. Food and Drug Administration (FDA) is making efforts to modernize both the 510(k) approval process for medical devices and study designs for drugs and biologics.
October 4, 2023
The FDA recently released three draft guidance documents that aim to "modernize" the 510(k) premarket notification process. This process permits medical device manufacturers to market...
October 3, 2023
Delaware Supreme Court Rejects No-Injury Medical Monitoring Claims - As part of our ongoing coverage of issues in Medical Monitoring, we noted that the Delaware Supreme...
September 28, 2023
On September 6, 2023, the FDA released three draft guidance documents that seek to "modernize" the 510(k) premarket notification process. Ever since the FDA first proposed "transformative...
September 18, 2023
On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more...
September 15, 2023
On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the...
February 1, 2022
/PRNewswire/ -- Final days to register for the "Navigating through Maze of In-vitro Diagnostics (IVD) Regulations Course: A systematic approach from Regulatory...