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...
Canada
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, issued a compliance program describing the inspections related to CDER-led or CDRH-led combination products. The document provides the requirements for different...
Canada
The Health Products and Food Branch of Health Canada, the Canadian regulating authority in the sphere of medical devices, issued a notice on the expansion of the medical device Regulatory Enrolment Process (REP) pilot program. Regulatory Enrolment Process: Regulatory...
FDA
The European Commission issued a Question and Answer document in order to provide medical device manufacturers with the information regarding the way the new Manufacturer Incident Report (MIR) Form shall be implemented. New Manufacturer Incident Report Form in Brief...
