In early August 2016, the US Food and Drug Administration’s (FDA or Agency) Center for Device and Radiological Health (CDRH) issued a Draft Guidance for industry entitled Deciding When to Submit a 510(k) for a Software Change to an Existing Device (Draft Guidance). When finalized, the guidance will assist industry and CDRH in determining when a software (including firmware) change to a 510(k)-cleared or a pre-amendments device subject to 510(k) (existing devices) may require a manufacturer to submit and obtain FDA clearance of a new premarket notification (510(k)).
FDA also announced a second draft guidance to industry on Deciding When to Submit a 510(k) for a Change to an Existing Device, which would supersede FDA’s 1997 guidance of the same name when finalized. This new draft guidance addresses non-software modifications.
FDA regulations require medical device manufacturers to provide notification to FDA when the entity intends to significantly change or modify the design, components, method of manufacturer, or intended use of the device. In particular, 21 C.F.R. § 807.81(a)(3) requires manufacturers to submit a premarket notification to FDA if the “change or modification in the device  could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process,” or a “major change or modification in the intended use of the device.” FDA’s 1997 guidance attempted to clarify when a change could trigger a new 510(k), but FDA recognized that the phrase “could significantly affect the safety or effectiveness of the device” and the use of the adjectives “major” and “significant” have lead FDA and device manufacturers to different interpretations.
For purposes of the Draft Guidance, FDA defined “software” to mean a “set of electronic instructions used to control the actions or output of a medical device, to provide input to or output from a medical device, or to provide the actions of a medical device.”
The Draft Guidance provides industry with a flowchart, text with considerations, and examples (Appendix A of the Draft Guidance) of the most common software modifications to help manufacturers decide whether to submit a new 510(k) for a software change to an existing device. FDA explained that manufacturers should use the flowchart in concert with the guiding principles noted above, as well as additional factors discussed below in Section IV of this advisory. FDA further explained that in deciding whether to submit a new 510(k) for changes, the manufacturer’s basis for comparison of any changed device should be the device described in the most recently cleared 510(k) or to the legally-marketed pre-amendments device.
To read more about the Draft Guidance, please read our Advisory.