The U.S. Food and Drug Administration (FDA) is telling U.S. manufacturers to be careful when importing medical devices, electronic products, and device components from Japan.
The communiqué follows the March 11 earthquake and tsunami that caused the release of radioactivity from one of the country's nuclear power facilities.
The FDA emphasized that neither its Center for Devices and Radiological Health (CDRH) nor the Center for Biologics Evaluation and Research (CBER) has been notified of any defective products or serious adverse events associated with the use of a device related to this disaster.
Still, the CDRH and CBER have concerns about manufacturing conditions as a result of the earthquake and tsunami that could impact the safety and effectiveness of medical devices exported from Japan to the U.S.
The FDA's concerns include radioactive contamination of devices and/or device components, as well as the potential for radioactively contaminated device implants to act as reservoirs for internal radiation exposure of patients.
