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The FDA will now allow certain devices to carry stand-alone symbols on labels, in an effort to harmonize international standards used in medical device labeling. Read More
If the FDA conducts a benefit-risk assessment and finds the device has a high benefit to patients and the compliance issue causes little risk, it may decide to work with a company informally, rather than taking an official enforcement action. Read More
Monteris Medical initiated a nationwide recall of its SideFire Select 2.2 mm Directional Laser Probe, following reports of fracture that resulted in CO2 introduction in the brain. 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
Having a risk tool to determine what situations require corrective and preventive actions is one strategy devicemakers can use to avoid repeat CAPAs. Read More
The World Health Organization has published a model regulatory guidance for medical devices and IVDs intended to support developing nations that have yet to develop regulations covering medical devices. Read More
Renovis Surgical Technologies received a strong warning from the FDA over its failure to conform to quality system regulations covering design verification, process validation, product development requirements and risk analysis. 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