This week MassMEDIC submitted its comments on the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health’s draft guidance document relative to filing a 510(k) for changes to an existing device. This was in response to the request for comments as stated in the Federal Register notice Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device published in Fed. Reg. Vol. 78, No. 47 (March 11, 2013).