RegDesk Regulatory Roundup

May 12, 2022

EFDA Guidance on Medical Device Labeling: Location and Content

The new article describes in detail certain specific aspects related to the labeling for medical devices intended to be marketed and used in Ethiopia, including the way the labeling should be placed and the information it should contain. ...

FDA Guidance on Good Manufacturing Practice Labeling Requirements

Aug 18, 2021

FDA

FDA Guidance on Good Manufacturing Practice Labeling Requirements

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 Guidance on Labeling for In Vitro Diagnostic Devices

Aug 9, 2021

FDA

FDA Guidance on Labeling for In Vitro Diagnostic Devices

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...

Jul 30, 2021

FDA

FDA Guidance on General Device Labeling

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...

FDA on General Principles of Labeling for Medical Devices

Jul 19, 2021

FDA

FDA on General Principles of Labeling for Medical Devices

The core principles of the regulatory approach for labeling for medical devices are described in a guidance document issued by the Food and Drug Administration (FDA or the Agency), the US regulating authority, earlier in 1989. Since that time, the document has been...