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The FDA’s draft guidances for OTC and prescription point-of-care blood glucose tests create overly burdensome clinical trial requirements that may chill development of new products, stakeholders say. Read More
Devicemakers importing goods for sale in Europe will need to comply with a revised hazardous substances directive if they are deemed “free for circulation on the EU market,” an industry guidance says. Read More
Citing continuing confusion among devicemakers regarding borderline products, the UK’s Medicines and Healthcare products Regulatory Agency last month issued guidance clarifying when they qualify as a medical device in the EU. Read More
China’s State Council last month approved the Medical Device Regulations (Amendment Bill), framework, paving the way for broad changes in device classification, adverse event reporting and monitoring of quality in device manufacturing. Read More
The current kerfuffle around online direct-to-consumer genetic testing service 23andMe.com came out of “a perfect storm” that led to the widespread marketing of such tests, experts say. Read More