In an effort to reduce confusion among manufacturers whose medical devices are subject to the agency’s review, the U.S. Food and Drug Administration (FDA) has published an updated version of its guidance on when changes to a given device require the submission of a new premarket notification (510(k)).
The guidance, entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device,” is intended to help device manufacturers determine when a proposed change is likely to exceed the regulatory threshold for the submission and clearance of a new 510(k). According to the FDA, a further intent is “to enhance the predictability, consistency and transparency of the ‘when-to-submit’ decision-making process by…describing in greater detail the regulatory framework, policies and practices underlying such a decision.”
The guidance does not address changes to devices that are exempt from the 510(k) process, or that are subject to the more extensive premarket approval (PMA) route.
The original version of the guidance was first published in 1997, and underwent an initial draft revision in 2016. The final, updated guidance was published in late October. Like all guidance documents issued by the FDA and other U.S. federal agencies, the current guidance is intended solely to provide insight into the agency’s current thinking on a topic and does not establish legally-enforceable responsibilities.