Deciding When To Submit a 510(k) for a Software Change to an Existing Device; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Deciding When to Submit a 510(k) for a Software Change to an Existing Device.'' FDA is issuing this final guidance document to clarify when a software change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA. FDA is correcting an error in the docket number assigned to the ``Deciding When to Submit a 510(k) for a Software Change to an Existing Device'' notice of availability when it published in the Federal Register (81 FR 52441, August 8, 2016). The docket number currently is FDA-2011-D-0453. FDA is changing the docket number to FDA-2016-D-2021. This action is administrative in nature and is being taken to avoid any potential confusion in the docket.