FDA Publishes FY 2016 Medical Device and Generic Drug User Fees
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...
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How Many Unique Device Identifiers (UDIs) Will You Need?
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...
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FDA Publishes Draft Guidance for UDI Direct Marking
On June 23, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance regarding the placement of unique device identifiers (UDIs) directly onto devices.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...
View ArticleRegistrar Corp to Present UDI Regulation Seminar at FIME 2014
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...
View ArticleTop 10 Changes to U.S. FDA Medical Device Registrations and Listings
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View Article(English) Changes in U.S. Medical Device Establishment Registration and...
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View ArticleFDA Proposes Unique Device Identifier System for Medical Devices
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View ArticleManufacturers, Exporters and Initial Importers/Distributors of Sunglasses and...
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View ArticleHave you renewed your Medical Device Establishment registration with the U.S....
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