The Association of Medical Device Reprocessors (AMDR) submitted comments on November 7, 2012 in response to the Food and Drug Administration’s (FDA) proposed rule (published July 10, 2012 in the Federal Register) on the Unique Device Identification system.  Overall, AMDR commends FDA for soliciting input on this important issue, underscoring the agency’s commitment to the adequate identification of medical devices through distribution and use. Moreover, AMDR echoes the sentiments expressed by FDA that adequate identification of medical devices through a universally-accepted system will accomplish several important public health objectives, including reduced medical errors, increased efficiency of product recalls, improved adverse event reporting, and targeted safety communications from FDA.
Click Here to view comments by AMDR and over 250 others on the proposed Unique Device Identification system