The US Food and Drugs Administration (FDA) has published two new guidance documents intended to help manufacturers to decide if the submission of a new 510(k) is required for changes to existing medical devices.
Although no significant changes to FDA’s opinion are introduced with this update, it is meant to improve clarity and consistency in the decision-making process. Usefully, both guidances include examples of changes with their corresponding questions and final decisions. One document is specifically intended to address the changes made to software components of devices.
Have a look at the final documents for devices by clicking on the shortened titles below: