Federal Register Notice: FDA is making available a guidance entitled Bundling Multiple Devices or Multiple Indications in a Single Submission. This guidance describes FDA's policy on bundling multiple devices or multiple indications in a single premarket submission. Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the bundling policy takes on additional importance because of the fees that are now associated with certain submissions as well as the performance goals the agency has committed to meet. To download this guidance, click here. To view this notice, click here.
