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:

  • Partnering with other national regulators to form global coalitions to uphold global product safety
  • Developing international data information and sharing systems
  • Building additional data gathering and analysis tools for risk analytics and information technology
  • Incorporating third-party and industry work for better allocation of FDA resources based on risk

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.


  • Stewart Eisenhart