By Stewart Eisenhart, Emergo Group
The FDA recently announced that the annual period for medical device establishment registration renewal has been extended by one month. The fiscal year 2013 (October 1, 2012 through September 30, 2013) registration renewal period was originally scheduled to end on December 31, 2012. Thanks to the extension, manufacturers now have until January 31, 2013 to renew their establishment registration.
The purpose of the extension is to allow establishments more time to comply with changed requirements regarding registration and medical device listing. The changes require all finished medical device manufacturers (including contract manufacturers and contract sterilizers) to register with the FDA. In addition, each owner or operator must identify one contact person within their organization who will be responsible for creating a master account in FURLS (FDA Unified Registration and Listing System).
The FDA will also make certain enhancements to the DRLM (Device Registration and Listing Module). Forthcoming upgrades will support the upload of spreadsheets to identify importers of foreign devices (for each listing); and the upload of a single spreadsheet containing proprietary names for all device listings associated with an establishment. This change is purportedly to take place around December 17, 2012.
As a reminder, the initial importer needs to be identified in each manufacturer’s registration in FURLS. It appears that the FDA will eventually allow foreign establishments who offer their goods for export, but who are not yet exporting in to the US, to register without specifying an importer. Until now FURLS has required that the initial US importer be identified.
While the above changes are a result of US legislation, this is a global regulatory theme that reflects enhanced collection of information about manufacturers, medical devices – and to borrow the EU term – “economic operators.”
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
