The US FDA has issued a draft guidance to update and clarify the 510(k) submission decision-making process for manufacturers whose devices have been modified. The guidance follows the controversial 2011 draft, which was withdrawn after Congressional Intervention.
Archives for September 2016
An area we see regular problems is device suppliers struggling to achieve transfer of sponsorship in the case of changes in distribution arrangements or other corporate restructures. TGA has a simple process where a sponsorship can be transferred to a new owner providing both parties sign off on the transfer. But if the current sponsor refuses to sign, this can lead to a world of pain and quite likely a need to start the whole regulatory process again to establish a new registration causing a delay on continued supply to market. There is no alternative if the existing sponsor cancels the entry.
The United States Food and Drug Administration (FDA) published a final rule in 2013 which outlined additional labelling requirements for manufacturers of Medical Devices being supplied in the United States in an attempt to improve the trace-ability. This introduced the Unique Device Identifier (or now known as the UDI) to manufacturers around the world.