The move will allow manufacturers to determine when they are required to notify the agency on changes made to several medical devices that already on the market.
The draft guidance recommendations include guiding principles, which recommend manufacturers to carry out a risk-based assessment to determine whether a modification could significantly affect the safety or effectiveness of the device.
The updated sections and flow charts will enable manufacturers to know when they are required to submit a new 510(k) for labeling, materials, technology, engineering and performance changes.
It also offers examples of specific device changes that likely require a new 510(k) and ones that likely do not in order to help guide manufacturers during their own decision-making on whether to submit a new premarket notification.
In addition, the FDA drafted a separate guidance to address changes that are specific to software. It complements the general 510(k) modifications draft guidance
FDA center for devices and radiological health director Dr Jeffrey Shuren said: “These draft recommendations are intended to help manufacturers determine when a change is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness.
“Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review.”
