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With the FDA expected to issue final guidelines on laboratory-developed tests in the coming months, devicemakers should take steps now to ensure their quality systems are in place, an industry expert says. Read More
Manufacturers of electrically powered medical devices should provide information, such as summary testing and specifications, to demonstrate their products don’t pose a risk of electromagnetic interference. Read More
The FDA is terminating its ISO 13485:2003 Voluntary Audit Report Pilot program effective March 31, in an effort to help manufacturers transition over to the Medical Device Single Audit Program. Read More
The FDA is seeking input from stakeholders on potential solutions to address the scientific and regulatory challenges for a certain type of point of care in vitro diagnostic that monitors warfarin. Read More
China’s FDA has unveiled plans to assemble an expert committee to review and discuss medical device classification, as well as spelling out the rules for using generic names for devices. Read More
Devicemakers should submit a letter of intent to the European Medicines Agency at least six months in advance before they plan to seek an initial consultation on an ancillary medical substance or ancillary human blood derivative incorporated in a device, according to a new question & answer guidance. Read More
Negotiations continue to move forward for the fourth installment of the Medical Device User Fee Act, with FDA and industry representatives focusing attention on improving performance of the review process. Read More
The FDA has given its final word on how sponsors of implantable minimally invasive glaucoma surgical devices should conduct clinical and nonclinical studies to support a premarket approval. Read More