FDA’s Center for Devices and Radiological Health called for feedback from stakeholders on its priorities for developing guidance for the year ahead. Read More
Health Canada released a three-part action plan aimed at improving how devices get on the market, strengthening monitoring and providing more information to consumers about the devices they use. Read More
Inadequate corrective and preventive action procedures and improper procedures for rework of nonconforming product landed devicemaker Zevex in hot water with the FDA following a Sept. 4 to Sept. 17 inspection of its Salt Lake City, Utah ... Read More
Devicemaker Winfield Laboratories was unable to produce quality control documentation for its N-Terface dressing, a Sept. 24 to Sept. 25 FDA inspection of the Richardson, Texas, facility revealed. Read More
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