Feb 4, 2019
EU MDR/IVDR
According to the interim report on the work of the Executive Working Group (EWG), the European Union and United States will work together to make sure their electronic database specifications for Unique Device Identifiers (UDIs) properly align. They will also...
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Dec 19, 2018
North America
The institution responsible for regulating medical devices in the United States is the Food and Drug Administration (FDA). The FDA uses a risk-based classification system, which classifies medical devices into the following three categories: Class I, Class II, and...
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Aug 13, 2015
Europe
Over the last two decades, biologics have revolutionized the treatment of illnesses such as diabetes, cancer, rheumatoid arthritis and hepatitis. However, many prominent biologics are about to have their patents expire in the U.S., making way for biosimilars....
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Aug 3, 2015
North America
The Food and Drug Administration has announced that it will be increasing the fee rates and payment procedures for medical device user fees by 4.2%. What is the Medical Device User Fee? Originally established in 2002 by the Medical Device User Fee and Modernization...
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