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Posts tagged ‘medical devices’

In early August each year, the U.S. Food and Drug Administration (FDA) publishes various user fee rates for the upcoming fiscal year (October 1 to September 30). On August 3, 2015, FDA published its medical device and generic drug user fee rates for fiscal year (FY) 2016. Medical Device User Fees FDA has authority to […]

You may be surprised by the number of different Unique Device Identifiers (UDIs) a company may need for a single type of device. A separate UDI is needed for certain variables, such as: Size Color Material Style Package Size For example, if the same surgical glove was available in latex and vinyl, each glove would […]

On June 23, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance regarding the placement of unique device identifiers (UDIs) directly onto devices.  Most devices will soon be required to bear a UDI on their labels and packaging.  For a device that is intended to be used more than once and intended […]

On August 6, Registrar Corp is heading to Miami, Florida to host a seminar about the U.S. Food and Drug Administration (FDA) Unique Device Identification (UDI) regulation at FIME’s 24th Annual Education Conference. In September 2013, FDA released a final rule requiring most domestic and foreign medical devices distributed in the U.S. to carry a […]

The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) imposes many Medical Device Establishment Registration and Listings requirements, effective October 1, 2012. To assist the medical device industry, Registrar Corp has provided the following list of top 10 things that medical device professionals need to know regarding FDASIA: All proprietary names under […]

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