North America - Aug 2020
Canada: Regulatory Enrolment Process (REP) pilot expanded to include private label applications and amendments
Canada: Temporary rules for conduct of, and access to, clinical trials for COVID-19 related devices and drugs
USA: New compliance programme for inspections of CDER- and CDRH-led combination products
USA: Five types of Class II devices exempted from pre-market notification requirements
USA: Revised UDI compliance policy for Class I/unclassified devices plus certain devices requiring direct marking
USA: Help for small entities to comply with reclassification of posterior cervical screw systems
USA: Upcoming changes to the electronic medical device reporting (eMDR) system
USA: Regulatory submissions for medical devices in electronic format are subject of new guidance document
USA: Recommendations for clinical investigations of prostate tissue ablation devices
USA: Updated guidance on device establishment inspections
USA: FDA prepares for resumption of domestic inspections with new risk assessment system
USA: Latest guidance issued in relation to COVID-19
USA: Comments sought on select updates to guidance on non‐clinical/clinical investigation of devices used for the treatment of BPH
USA: Proposed updates to guidance on 510(k)s for peripheral vascular atherectomy devices
USA: The Food and Drug Administration (FDA) periodically initiates new policies and pilot programmes to help improve consistency and efficiency in 510(k) reviews.
USA: The US Food and Drug Administration is to develop clearer, more feasible reprocessing instructions for dental devices to avoid potential transmission of infection or inflammation due to contamination remaining on the device after reprocessing.
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