North America - May 2018

  • Canada: Medical device fees increased by 2% from 1 April 2018

  • Canada: New Digital Health Review Division to be established

  • Canada: Classification and licensing of high-level disinfectants and sterilants as medical devices

  • Canada: Adjustments to the MDSAP transition process

  • Canada: Strengthening medical device post-market surveillance and risk management

  • Canada: Updated guidance on the classification of health products at the device-drug interface

  • USA: Lynch syndrome test system classified into Class II

  • USA: Percutaneous nerve stimulator for substance use disorders has been classified into Class II

  • USA: Temporary catheter for embolic protection during transcatheter intracardiac procedures has been classified into Class II

  • USA: Class II classification for the non-absorbable, haemostatic gauze for temporary internal use

  • USA: Class II classification deemed appropriate for the surgical smoke precipitator

  • USA: Class II classification for the extracorporeal shock wave device for treatment of chronic wounds

  • USA: Revised rules for the acceptance of data from clinical investigations of medical devices

  • USA: Delay of effective date: when products made/derived from tobacco are regulated as drugs, devices or combination products; amendments to regulations regarding intended uses

  • USA: OTC denture repair kits exempt from pre-market notification (510(k)) requirements

  • USA: Technical amendments to the medical device regulations

  • USA: Post-market safety reporting for combination products

  • USA: New guidance for industry released on how to prepare a Pre-Request for Designation

  • USA: Revised guidance released on acceptance and filing reviews for PMAs

  • USA: Updated guidance published on the Refuse to Accept Policy for 510(k)s

  • USA: Policy clarification and 510(k) submissions for ultrasonic diathermy devices

  • USA: Two guidance documents published to support the development of NGS-based tests

  • USA: Proposed expansion of the abbreviated 510(k) programme to permit demonstration of substantial equivalence using performance criteria

  • USA: Medical Device Safety Action Plan

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