Concerns about Medical Devices and Components from Japan

Wednesday, July 13, 2011


Concerns about Medical Devices and Components Imported from Japan



The Food and Drug Administration (FDA) has expressed concern that the earthquake and tsunami which occurred in Japan on March 11, 2011, may possibly affect Japan’s manufacturing integrity of medical devices, electronic products and device components intended for the U.S. market.  Given the extent of the devastation, FDA is concerned that manufacturing conditions in Japan have the potential for the following:


·         Radioactive contamination of

devices and/or device components

·         Contaminated water supply that could

result in defective products

·         Loss of electrical power which directly

impacts the manufacturing process

·         Compromise in sterile products during

or after production

·         Compromise in the reliability of product


·         Damaged and/or disrupted medical

device manufacturing facilities that

could result in a shortage of

components and/or finished devices


FDA encourages all device manufacturers and distributors to take increased precautions to provide assurance of the safety and effectiveness of their products as described in Title 21, Code of Federal Regulations (CFR), Part 820.  The FDA has published a notice that lists recommendations of precautionary actions and contact information regarding this issue.


We advise importers of such devices to read the entire notice.


FDA Notice