What Happens to Medical Device Reports Once They Reach FDA?

January 11, 2011

Hyman, Phelps & McNamara, P.C.'s Jeff Shapiro published an article in this month's MD&DI magazine -  What Happens to Medical Device Reports Once They Reach FDA?  In the article, he summarizes a Office of Inspector General Report finding that FDA has not used medical device reporting ("MDR") data to improve medical device safety.  He suggests that eliminating malfunction MDRs would significantly reduce the burden on industry and FDA, and would allow FDA to better focus on device problems that cause actual serious injuries or deaths.

Categories: Medical Devices