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The lawmakers pointed to recent cyber attacks that highlighted the vulnerabilities and unpreparedness of the healthcare sector to “increasingly sophisticated and rapidly evolving cyber threats.” Read More
The FDA issued a warning to Florida-based ProSun International, a tanning bed manufacturer, over significant GMP and branding violations revealed during an August inspection. Read More
The Department of Homeland Security issued a warning about two security vulnerabilities in Boston Scientific’s portable cardiac rhythm management systems. Read More
The agency said the contraindication should be added to labeling of the devices, with or without 510(k) clearance, within 120 days of the Oct. 30 release of the guidance. Read More
The Government Accountability Office said medical device companies lack incentive to enroll participants in a post-market safety study requested by the FDA, and are slow to report findings. Read More
The FDA has recommended the addition of a contraindication for the use of certain ultrasonic surgical aspirator devices for removing uterine fibroids. Read More
An inspection in March by the FDA of ELITech Group’s facility in Spankeren, The Netherlands prompted a warning letter after the device manufacturer failed to follow through with the promises made in response to a Form 483 report. Read More
Inadequate processes for validating the facility’s water system, controlling purchased products and accepting incoming products were some of the issues flagged. Read More
A CAPA report showed manufacturing errors that led to many low patient results were caused by a failure to update manufacturing procedures after a design change, the agency said. Read More