FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a detailed guidance document dedicated to labeling requirements for various types of medical devices, including in vitro diagnostic...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a general guidance document dedicated to labeling for medical devices. The document describes in detail the general labeling...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, continuously develops and publishes guidance documents dedicated to various medical devices. In these documents, the FDA addresses the most...
FDA
The Food and Drug Administration (FDA or the Agency), the country’s regulating authority in the sphere of healthcare products, has developed detailed guidelines dedicated to labeling requirements for various types of medical devices. The present article supplements...
North America
This article was updated June 2, 2025. The FDA finalized guidance in 2019 regarding placebos and blinding. FDA’s Guidance on Placebos:A placebo is an inactive substance or procedure used in clinical trials to determine whether participant responses result from...
