AdvaMed Comments on FDA Report on the Quality, Safety and Effectiveness of Servicing of Medical Devices

AdvaMed submitted these comments in response to the Food and Drug Administration’s (FDA’s) invitation for comments on FDA’s Report on the Quality, Safety and Effectiveness of Servicing of Medical Devices in Accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA). While FDA made a good faith effort to be responsive to the questions posed by Congress in FDARA, there are a number of areas and recommendations in the report where we outline our perspective which differs from the FDA’s in key respects.