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The U.S. Food and Drug Administration is proposing a new, voluntary program to speed the approval of devices that address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions. Read More
Physicians are calling on the European Parliament and the Council of the European Union to relax genetic counseling requirements in the In Vitro Diagnostic Device Regulation, saying they will restrict patients’ right to essential testing. Read More
Argentina’s ANMAT has adopted strict traceability requirements for medical devices, with the aim of stemming the flow of counterfeit products. Read More
The South Korean government is proposing strict quality controls to ensure the safety of unregistered devices distributed during public health emergencies. Read More
Senate lawmakers want to give the FDA $2.588 billion in discretionary funds in the next fiscal year, a $36 million boost over current levels and $13 million more than a related House bill. Read More
Routine quality system surveillance inspections of foreign devicemakers increased by 93 percent in 2012, according to newly released FDA data. Overall QS inspections were up 37 percent for the year. Read More
There has been a steady uptick in the number of FDA 483s that cite inadequate supplier controls — from 84 in 2011, to 110 in 2012 and 126 last year. The problem is now one of the top five most common 483 findings for devicemakers. Read More
CINCINNATI — With September’s deadline for displaying unique device identifiers on high-risk devices just around the corner, rollout for many manufacturers is well underway. Read More