WARSAW — The U.S. FDA is defending its response to a delay in reporting by MedTronic of injuries allegedly caused by its Infuse bone growth product.
MassDevice cites a recent article by the Minneapolis StarTribune, which took an in-depth look at the situation and reported on MedTronic’s delay in reporting. The company disputed the story and U.S. Senator Al Franken wrote a letter to the FDA requesting answers.
The study was shut down in 2008 and more than 1,000 related injuries went unreported for five years. When the data was submitted, the FDA chose not to take action against MedTronic for the delay, stating the data was consistent with previous results already on the product.
To read more about the topic and to link back to the original article by the StarTribune, click here.