JD Supra

FDA Extends UDI and Direct Marking Enforcement Discretion for Class I and Unclassified Devices to 2022

The US Food and Drug Administration’s recent policy, issued in part due to the coronavirus (COVID-19) pandemic, also suspends enforcement of Direct Marking ...
Acsh.org

Recalling Medical Devices

Once a medical device is brought to market, FDA surveillance of its safety continues. “To facilitate incremental improvements in safety and effectiveness, the FDA allows manufacturers to modify ...
RAPS

FDA Moves Three Device Types into Class II Special Controls

The US Food and Drug Administration (FDA) has proposed classifying three types of medical device products into its Class II regulatory controls scheme, subjecting them to special controls meant to ...
RAPS

FDA Classifies Cellulite-Reducing Device as Class II

The US Food and Drug Administration (FDA) has announced that it will soon classify surgical instruments intended to improve "the appearance of cellulite" as Class II medical devices, making it easier ...
Becker's Hospital Review

1 month until all Class II devices must be labeled with UDIs

Starting September 24, the Food and Drug Administration will require all Class II devices to be labeled with unique device identifiers. The FDA introduced the unique device identifier system in 2013 ...
News Medical

Medical Device Categories Explained

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...