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The FDA lacks a good mechanism for dealing with the hundreds of device accessories currently on the market which may be inappropriately classified, and a new House bill proposes to streamline the process. Read More
The president signed into law on May 5 a spending bill for fiscal 2017 that keeps the federal government running through September and gives a modest funding increase to the FDA and $428 million for CDRH. Read More
The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published Friday in the Official Journal of the European Union. Read More
South Africa’s Medicines Control Council (MCC) released a draft guideline listing minimum requirements for quality manuals that medical device importers, manufacturers, distributers, exporters, and wholesalers must maintain. Read More