COVID-19
The Food and Drug Administration (FDA or the Agency), a US authority responsible for medical device regulation, issued guidance to provide recommendations for industry representatives applying for the Emergency Use Authorization (EUA) for decontamination and bioburden...
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...
COVID-19
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices, issued guidance dedicated to formal meetings and user fee applications for medical devices in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19)...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, put out a statement to finalize the process of feedback and received comments from industry representatives regarding public consultations on the scope of...
The European Commission (EC), the medical device regulating authority of the European Union, issued a new regulation regarding standardization aspects in the context of Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation...
