Which type of supplement would be used if a device undergoes a labeling change that enhances safety?

The correct type of supplement for a device that undergoes a labeling change that enhances safety is a Special PMA Supplement. This is because any significant modifications to a device's labeling that address safety concerns are regarded as important changes that require thorough review by the FDA.

A Special PMA Supplement is specifically designed for modifications that may impact the safety or effectiveness of the device, thus necessitating a more comprehensive evaluation during the review process. The focus on safety in this scenario means that the FDA must ensure that the updated labeling provides adequate information for safe and effective use, highlighting the need for a formal submission to account for these changes.

Other types of supplements, such as the 30-Day Notice, Real-Time Supplement, and 180-Day Supplement, are suitable for different circumstances and may not adequately reflect the safety focus required by labeling changes. For example, the 30-Day Notice is generally used for administrative changes or modifications that do not significantly affect safety or effectiveness, while the 180-Day Supplement is more suitable for changes that do not represent substantial improvements but nevertheless require FDA notification. The Real-Time Supplement can be employed for urgent updates but isn't typically reserved for safety-related labeling changes. Each of these options has its specific use cases that are distinct from the requirement