North America - Mar 2019

March 29, 2019

  • Canada: Non-compliant device labels may now be relabelled/corrected after importation

  • Canada: Priority review process for device applications to be streamlined and expanded

  • Canada: Guidance on the requirements for recognising an MDSAP Auditing Organization

  • Canada: Consultation on pre-market requirements for medical device cybersecurity

  • Canada: Draft guidance on licensing requirements for 3D printed medical devices

  • Canada: ‘Action Plan on Medical Devices’ is released

  • USA: Incorporating FDASIA modifications to the medical device classification procedures

  • USA: Reclassification of ECT devices; effective date of requirement for a PMA for ECT devices for certain specified intended uses

  • USA: Insulin therapy adjustment devices placed into Class II

  • USA: Class II classification for the active implantable bone conduction hearing system

  • USA: Class II classification deemed appropriate for the high flow humidified oxygen delivery device

  • USA: Meprobamate test system classified into Class II

  • USA: Withdrawal of proposed rules on laser products’ performance standard and electronic labelling submission for certain home-use devices

  • USA: Proposed regulation of medical device de novo classification process

  • USA: Proposal to end temporary extension of GUDID’s grace period

  • USA: Revised policy on UDI direct marking compliance dates

  • USA: Policies for implementing Breakthrough Devices Program set out in new guidance

  • USA: Guidance released on manufacturing site change supplements

  • USA: Comments sought on draft guidance concerning blood glucose monitoring test systems for prescription point-of-care use

  • USA: Draft guidance issued on self-monitoring blood glucose test systems for over-the-counter use

  • USA: Guidance drafted on developing and labelling in vitro companion diagnostics for a specific group or class of oncology therapeutic products

  • USA: Draft guidance documents concerning CLIA waiver applications revised and re-issued

  • USA: Further plans to modernise the pre-market notification (510(k)) programme

  • USA: ‘Medical Device Enforcement and Quality Report’ shows improved compliance rates

 

 

 

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