Jun 20, 2011
The US Food and Drug Administration (FDA) has launched a new strategy detailed in a new report, the Pathway to Global Product Safety and Quality, to better monitor increasing numbers of imported medical devices and other regulated products hitting the US market.
The report calls for a more global approach to regulation of products that fall under the FDA’s purview, recommending four initiatives to carry out the new strategy:
In an agency press release, FDA commissioner Margaret Hamburg noted that FDA-regulated imports have risen fourfold over the past decade, and that trend will only continue in the future. The FDA has already stepped up inspections of foreign drug manufacturers since 2007, according to the press release, as well as opened international offices and increased collaborative efforts with European and Australian regulators.
Setting up a more collaborative global regulatory framework and a shared database of regulated products could make it more efficient (if not easier) for foreign medical device manufacturers to gain entry into the US market. Turning strategy into policy, however, will take no small amount of time.
A new study sponsored by the US medical device industry trade association Advanced Medical Technology Association (AdvaMed), “EU Medical Device Approval Safety Assessment,” has found that the European regulatory system has performed just as effectively in terms of public safety as the US Food and Drug Administration while simultaneously providing a speedier and more efficient path to market for manufacturers.
The US FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) have issued a notice warning of possible effects the ongoing nuclear disaster in Japan may have on medical device components exported to the US.
The FDA's Center for Devices and Radiological Health (CDRH) has published a Letter to Industry dated 24 March 2011 outlining information importers should provide to ensure expedited entry of th