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Dechert Re:Torts - Issue 9 | Dechert LLP

FDA Releases New Draft Guidance Documents To Modernize The 510(k) Process - Product Liability & Safety

On September 6, 2023, the FDA released three draft guidance documents that seek to "modernize" the 510(k) premarket notification process.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.

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On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the.

FDA Guidance for Premarket Notifications of Medical Devices

FDA Guidance for Premarket Notifications of Medical Devices
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