The FDA has released draft guidance clarifying when device modifications trigger the need for a new premarket review, or 510(k) submission. When finalized, it will supersede the previous 1997 guidance on the subject.
“The recommendations in this draft guidance document are consistent with longstanding FDA policy for when a modification to a device does and does not require the submission of a 510(k),” the draft stated. “The guidance has been updated, however, to address issues associated with software and other rapidly changing technologies, and to provide greater clarity about the changes that do not trigger the need for a new premarket submission.”
The FDA previously clarified when device changes require a new 510(k) submission in the 1997 publication of “ Deciding When to Submit a 510(k) for a Change to an Existing 510(k).” That is the current guiding document until the new guidance takes effect.
FDA regulations require a new 510(k) for any device that “could significantly affect” either the safety or effectiveness of a device.
“Whether a change does affect safety and effectiveness is typically demonstrated by testing submitted in a 510(k) application. In most cases testing cannot, however, conclusively show that a change could not affect safety and effectiveness,” the guidance stated. “We have developed this draft guidance to categorize the types of changes likely to require new 510(k) submissions, and to identify gray areas where we recommend sponsors speak to the agency before determining whether a new 510(k) should be submitted.”
The draft addressed the following types of changes: manufacturing changes, labeling changes, technology or performance specification changes and materials changes. It provides examples of changes that would or would not require a new submission.
The FDA will accept public comment on the draft guidance until Oct. 25.