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The FDA is providing devicemakers with clarity on what to submit to support claims of electromagnetic compatability for premarket submissions, humanitarian device exemptions, premarket notifications and de novo requests. Read More
Devicemakers in the UK that remanufacture single-use devices must accept all the obligations and liabilities that an original manufacturer would face, the regulator said. Read More
In yet another move toward precision medicine this week, the FDA is mapping out co-development pathways for companion diagnostic devices to accompany targeted therapies. Read More
FDA is recommending that device manufacturers redesign heater-cooler devices used in surgeries because cleaning maintenance challenges have been linked to infections and patient deaths. Read More
FDA is incorporating a risk-based approach for analyzing biocompatibility of medical devices that come into direct or indirect contact with the body. Read More
The FDA will now allow certain devices to carry stand-alone symbols on labels, in an effort to harmonize international standards used in medical device labeling. Read More