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The FDA has classified continuous glucose monitor secondary displays, high throughput genomic sequence analyzers, and vibratory counter stimulation devices as Class II devices with special controls. Read More
Heater cooler units used in cardiopulmonary bypass and extracorporeal membrane oxygenation can generate potentially infectious aerosols containing a range of harmful bacteria, some of which can be fatal, according to an ongoing UK investigation. Read More
A manufacturing defect in MicroPort Orthopedics’ Biolox Forte 36 mm Alumina ceramic heads may cause surgical complications, according to Australia’s Therapeutic Goods Administration. Read More
The China Food and Drug Administration (CFDA) has established a permanent medical device recall program that requires manufacturers’ quality management systems to include event monitoring. Read More
Device manufacturers in China should integrate cybersecurity risk management into their quality management systems, according to new guidance from the China Food and Drug Administration. Read More