In the medical device industry, usability plays a critical role in ensuring the safety and effectiveness of highly complex medical products. The IEC 62366-1:2015 standard, which focuses on the ...
Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...
Connected medical devices can improve patient care and operational efficiency. However, they also introduce new privacy and security risks. Healthcare providers should rethink their privacy and ...
The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...
Medical device companies, whose user fees have funded an increasing share of Food & Drug Administration’s device review budget, will have a chance to weigh in on how well the program is working at a ...
To support the continued development and marketing of safe and effective medical devices enhanced by artificial intelligence, the U.S. Food and Drug Administration will offer marketing submission ...
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