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.


Click here for the full article on Global Regulatory Press.

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