When a change is made to a medical device or software, there can be confusion as to whether it is necessary to submit a premarket notification to the FDA. Although the agency issued a guidance document nearly 20 years ago with regulatory language that explained the process, FDA has decided to issue two new draft guidances to further clarify when a 510(k) submission is necessary.

The intention of the first draft guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device, when finalized, is to help manufacturers of devices “subject to premarket notification requirements who intend to modify a 510(k)-cleared device or a preamendments devices subject to 510(k) during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k). The draft guidance does not discuss changes to devices that are 510(k)-exempt or those that require a PMA.  Once final, the guidance document will supersede the original guidance issued on January 10, 1997.

The second draft guidance document, Deciding When to Submit a 510(k) for a Software Change to an Existing Device, contains updates from the original guidance document (Deciding When to Submit a 510(k) for a Change to an Existing Device) and specifically addresses modifications made to software, which, for purposes of the draft guidance, is defined as the set of electronic instructions used to control the actions or output of a medical device, to provide input to or output from a medical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”. According to FDA, the definition encompasses software that is embedded within or is a permanent component of a device, is an accessory to another device, or is intended to be used for medical purposes that isn’t part of the hardware of the medical device. The draft doesn’t address combination products.

“Updates in the draft guidance documents include clarifying key terms, explaining how to use risk assessment to evaluate whether or not a change requires a new 510(k), harmonization of flowcharts with the text of the guidance, examples of device changes that would or would not require a new 510(k), and recommendations for documenting decisions about whether or not to submit a new 510(k) for a device change,” according to an FDA statement.

The agency will be answering questions about the draft documents on Thursday, August 25.