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FDA Releases Draft Guidances on 510(k) Submissions | Knobbe Martens - Vimarsana News

FDA Releases Draft Guidances on 510(k) Submissions | Knobbe Martens

On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the...

Two Day In-vitro Diagnostics (IVD) Regulations Course: A Systematic Approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada (February 10-11, 2022) - Vimarsana News

Two Day In-vitro Diagnostics (IVD) Regulations Course: A Systematic Approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada (February 10-11, 2022)

/PRNewswire/ -- Final days to register for the "Navigating through Maze of In-vitro Diagnostics (IVD) Regulations Course: A systematic approach from Regulatory...