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FDA Issues Long-Awaited Final Clinical Decision Support Software Guidance

USA - September 30 2022 On September 28, 2022, the US Food and Drug Administration (FDA) issued its final Clinical Decision Support Software Guidance three years after the…

Anisa Mohanty

AdvaMed Updates Code to Provide Guidance on Innovative Arrangements, Medical Technology, Interactions with HCPs

USA - April 7 2022 The medical device industry has relied on the AdvaMed Code for decades to assist with navigating complex rules concerning compliance—particularly…

Kristina M. DiPano, James A. Cannatti III, Tony Maida, Anisa Mohanty

FDA Issues Final Guidance for Initiation of Voluntary Recalls

USA - March 7 2022 The US Food and Drug Administration (FDA) published its Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA…

Harrison R. Farmer, Anisa Mohanty

FDA Issues Proposed Rule to Amend Medical Device Quality System Regulation

USA - March 1 2022 The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical…

Kristina M. DiPano, Harrison R. Farmer, Anisa Mohanty

FDA Issues Proposed Rule to Amend Medical Device Quality System Regulation

USA - March 1 2022 The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical…

Kristina M. DiPano, Harrison R. Farmer, Anisa Mohanty