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Draft Guidance Offers Clarity On 510(k) Need for Software Modifications

FDA has outlined its thinking on when companies should consider filing a 510(k) when they make a software change to a medical device or software that acts as a standalone device.

A new draft guidance from FDA lays out a process and flowchart for companies when deciding whether they should file a 510(k) for software modifications on their medical devices. The document applies to not just software embedded in medical devices, but also to software that act as an accessory to other devices, or when the software stands alone.

The new proposed guideline is an outgrowth of a heavily used 1997 guidance detailing when companies should file 510(k)s if they make changes to their existing medical device. On Aug. 5, the agency issued a new draft to replace that broad-based guidance. (Also see "FDA Calls For Full Risk Reviews For Device Changes In 510(k) Modifications Draft" - Medtech Insight, 5 August, 2016

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