FDA recently issued two draft guidance documents to help clarify when a change in a legally marketed medical device requires a manufacturer to submit a premarket notification, or 510(k), to FDA. The first document, "Deciding When to Submit a 510(k) for a Change to an Existing Device," addresses non-software changes and, when finalized, will supersede guidance issued in 1997. The second document, "Deciding When to Submit a 510(k) for a Software Change to an Existing Device," focuses on software changes to devices, including adaptive, corrective, and perfective software modifications. Both guidance documents include guiding principles and points for manufacturers to consider when analyzing to what extent a change may affect a device's safety and effectiveness and determining whether FDA notification is required. For more information, see FDA's press release announcing the updated recommendations. Comments on both guidances are due November 7, 2016.
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