FDA
The Food and Drug Administration (FDA) issued guidance dedicated to unique device identification (UDI). The policy covers issues related to compliance dates for Class I and unclassified medical devices, and also certain devices requiring direct marking. The present...
Europe
The Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) issued guidance dedicated to the regulatory requirements of protective elements on colored drawings on medical device packages. In particular, the document describes specific aspects to be...
FDA
The Food and Drug Administration (FDA or the Agency) issued updated guidance on processes and standards for the inspections of medical device establishments. Inspections Regulatory Backgrounds The new approach to medical device establishment inspections is based on...
COVID-19
The Food and Drug Administration (FDA) issued guidance to provide recommendations for industry representatives applying for the Emergency Use Authorization (EUA) for decontamination and bioburden reduction systems. The document describes special extraordinary measures...
FDA
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical device regulation, announced amendments to the MDDT framework. Medical Device Development Tools (MDDT) The Agency published a notice dedicated to certain amendments made to...
Australia and Oceania
In relation to difficulties associated with the coronavirus, The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, issued a notice dedicated to the delay in the implementation of certain regulatory changes in...
