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The FDA offers new advice for devicemakers on 510(k) submissions for guidewires used in coronary, peripheral and neurovasculature in a final guidance released last week. Read More
A new final guidance from the FDA allows some sponsors of oncology products to file a single application for use of an investigational diagnostic in their trial rather than filing for the drug and device components separately. Read More
In a newly released guidance, the FDA spells out what manufacturers need to consider when labeling catheters, wires and delivery systems with lubricious coatings used during minimally invasive diagnostic and therapeutic vascular procedures. Read More
Devicemakers planning to market products in the European Union need to understand new EU rules that spell out when clinical research is required and impose requirements for conducting trials. Read More
Brazil’s ANVISA issued a new regulation for custom-made medical devices that includes new requirements for manufacturing, marketing and importing such devices. Read More
Some individuals “may be predisposed to develop a local or systemic immune or inflammatory reaction when exposed to certain metals contained in select implantable devices,” the agency said. Read More