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A Senate appropriations committee is requesting the FDA to provide documentation on de novo device approvals, classifications and postmarket surveillance standards. Read More
B. Braun Medical has agreed to resolve criminal liability allegations by paying $4.8 million in penalties and forfeiting an additional $4 million in restitution for selling contaminated pre-filled saline flush syringes in 2007, the Department of Justice announced. Read More
The FDA issued a warning letter to Eclipse Aesthetics because it had concerns that the firm’s MicroPen Elite dermabrasion device has the potential to damage vessels and nerves. Read More
The European Commission has published an updated version of harmonized standards that devicemakers and diagnostics makers can reference to ensure their products comply with relevant EU legislation. Read More
In a move aimed at ensuring the safety and effectiveness of marketed products, the FDA has updated its thinking on 522 postmarket surveillance studies for Class II and III devices. Read More
The FDA has provided details on how it plans to regulate diagnostics that detect infectious disease organisms, antimicrobial resistance and virulence markers. Read More