Which products does GHTF’s guidance on labeling cover?

The guidance from the Global Harmonization Task Force (GHTF) on labeling applies to both medical devices and in vitro diagnostic (IVD) devices, making the option that includes both categories the correct choice. This inclusion reflects the need for standardized labeling practices that ensure safety, effectiveness, and proper use of both types of products.

By addressing the labeling for medical devices, the guidance acknowledges the diverse range of products that fall under this classification, which includes everything from surgical instruments to implants. IVD devices, on the other hand, are critical in the diagnostic realm, involving products that test samples from patients and require accurate labeling to prevent misuse or misunderstanding of the test results.

This comprehensive approach highlights the GHTF’s goal of fostering consistency and clarity in labeling practices across varying product types, ultimately promoting patient safety and informed decision-making in healthcare settings. Therefore, the correct choice is the one that encompasses both medical and IVD devices.