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U.S. FDA Releases Report on Performance of Third Party Reviewers

The U.S. Food and Drug Administration (FDA) has released its first report on the...

FDA Issues Guidance on UDI Compliance Dates for Medical

The U.S. FDA has issued an “immediately in effect” guidance which roles back the compliance deadlines for its rules regarding labeling and data submission requirements applicable to unique device identification (UDI) systems in class I and unclassified medical devices

FDA Issues Final Guidance on Medical Device Accessories

The FDA has issued a final guidance on the appropriate description and classification of accessory products used in conjunction with medical devices.

FDA Issues Guidance for Additive-Manufactured Medical Devices

The U.S. Food and Drug Administration (FDA) has issued a final version of another...

Health Canada Proposes Fee Changes for Medical Device Applications

Canada’s regulatory department for medical devices has proposed sweeping changes to its application fee...
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China Exempts More High-Risk Medical Devices from Clinical Trials

In an apparent effort to increase access to China’s huge medical device market by...

FDA Issues Updated Guidance on Addressing Medical Device Changes

In an effort to reduce confusion among manufacturers whose medical devices are subject to...

New Handbook Helps Medical Devices Sector Improve its Quality Management System

New Handbook Helps Medical Devices Sector Improve its Quality Management System

Changes to China’s Medical Device Classification May Require New Registrations

A recently published medical device classification catalog issued by the China Food and Drug...

Moisture-Triggered Physically Transient Device that has Tunable Degradation Under the Presence of Moisture

Devices that can physically disappear in a controlled manner are a growing (and increasingly important) type of electronics.
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