As the effective dates for UDI Compliance and enforcement edge closer there is suddenly a huge waive of information that is becoming available on a daily basis with regard to the suggested best practices and necessary filing requirements of the new FDA regulations and GUDID filing system. Unfortunately, as is often the case with documentation surrounding a tidal shift in regulations of this enormous scale, some of the information is inadvertently erroneous – and finding concise, useful and reliable information in synopsis form can become increasingly difficult to locate for anyone now starting their data gathering efforts.
For these reasons, UDI Compliance Solutions is working with several of our strategic partners to aggregate the most valuable information into one universal set of documents chosen for their simplicity and accuracy. The first of these documents is the U.S. FDA UNIQUE DEVICE IDENTIFICATION (UDI) FREQUENTLY ASKED QUESTIONS R2.3 document which was originally released on MARCH 11, 2014. The document includes many useful definitions and explanations along with some exceptionally easy to track UDI Compliance charts like the one below showing effective dates for a variety of Classes and Devices: