North America - Jun 2019

June 28, 2019

  • Canada: Medical device fees increased by 2% from 1 April 2019

  • Canada: ‘Medical Devices Regulations’ updated to refer to 2016 edition of ISO 13485

  • Canada: Public to have access to clinical information on drugs and devices

  • Canada: Consultation held on draft guidance concerning software as a medical device

  • Canada: Publication of Draft Health Canada IMDRF ToC for Medical Device Applications Guidance

  • Canada: Publication of updated list of recognised standards for medical devices

  • USA: New acting FDA Commissioner

  • USA: CDRH undergoes period of reorganisation

  • USA: Ventilatory electrical impedance tomograph classified into Class II (special controls)

  • USA: Posterior cervical screw systems become Class II devices

  • USA: In vitro diagnostic devices for Bacillus species detection placed in to Class II

  • USA: Class II classification for software applications for contraceptives

  • USA: Auto titration device for oral appliances is classified into Class II

  • USA: Class II classification for the transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions

  • USA: Devices to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens are Class II devices

  • USA: Steps to reduce risks from use of surgical staplers for internal use and implantable staples

  • USA: Certain flow cytometer instruments to be exempted from 510(k) review

  • USA: Finalised list of accessories distinct from other devices and suitable for Class I

  • USA: Safety and performance based pathway described in final guidance

  • USA: Resources for implementing final rule on human subject protection; acceptance of data from clinical investigations for medical devices

  • USA: Certain unclassified medical devices are exempt from 510(k) requirements

  • USA: Guidance updated on post-market safety reporting for combination products

  • USA: New guidance covers issuing of public warnings about voluntary recalls and notification of recalls

  • USA: Guidance on evaluation of devices used with regenerative medicine advanced therapies

  • USA: Concept and principles of the least burdensome provisions are updated in guidance

  • USA: Updated guidance on devices containing materials derived from animal sources

  • USA: New guidance addresses coordinated development of antimicrobial drugs and AST devices

  • USA: Draft principles of pre-market pathways for combination products

  • USA: Standardised process for providing non-binding feedback after certain FDA device establishment inspections has been proposed

  • USA: Draft guidance on initiating voluntary product recalls

  • USA: Draft guidance recommends non-clinical testing and clinical considerations for implanted Brain-Computer Interface devices

  • USA: Review and update of device establishment inspection processes and standards

  • USA: Questions and answers drafted on a risk-based approach to monitoring clinical investigations

  • USA: Draft guidance issued on technical performance assessment of quantitative imaging in device pre-market submissions

  • USA: Technical considerations are proposed for non-clinical assessment of medical devices containing nitinol

  • USA: Proposed regulatory framework for modifications to artificial intelligence-/machine learning-based software as a medical device

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

  • USA: GUDID temporary grace period extension ends; HL7 SPL processing window reduced

  • USA: Clarification provided on difference between servicing and remanufacturing of medical imaging devices










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