Devicemakers Could Gain From Obama’s Order on Regulatory Harmonization

The U.S. Food and Drug Administration (FDA) may need to better match its regulations with those of key trading partners, a move that could benefit the increasingly global device industry, thanks to a new executive order (EO), 13609, signed by President Barack Obama May 1. The “Promoting International Regulatory Cooperation” order asks federal agencies to reform existing requirements that unnecessarily differ from those of U.S. major trading partners.
International Medical Device Regulatory Monitor