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North America - May 2021

  • Writer: ARQon
    ARQon
  • Jul 21, 2021
  • 1 min read

  • Canada: New Interim Orders are issued for importation and sale of medical devices for use in relation to COVID-19 and for reporting device shortages

  • USA: Classification regulations amended to exclude non-device software functions

  • USA: Withdrawal of proposal to exempt certain Class II/unclassified devices from pre-market notification

  • USA: Comments requested on need for a 510(k) for certain Class I medical gloves

  • USA: CMS delays rule designed to improve Medicare coverage of innovative medical devices

  • USA: Updates to the FDA’s eMDR system to align with IMDRF revisions

  • USA: New regulatory science tools available

  • USA: Modifications to the list of US FDA-recognised standards

  • USA: Latest medical device guidance issued in relation to COVID-19

Click here for the full article on Global Regulatory Press.

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