North America - Dec 2018

  • Canada: Changes to evidence requirements for Class II and Class III infusion pumps

  • Canada: Applications for medical device Investigational Testing Authorisations (ITAs)

  • Canada: Use of Regulatory Enrolment Process using the Common Electronic Submission Gateway to be piloted for medical devices; ToC format to be adopted

  • Canada: Pilot project to formalise a framework for offering regulatory advice to device manufacturers to be launched

  • Canada: Guidance on 3D printed devices in development

  • Canada: Proposed changes to the List of Recognised Standards for medical devices

  • USA: FDA medical device user fees for Fiscal Year 2019

  • USA: Voluntary Malfunction Summary Reporting Program to streamline malfunction reporting for certain devices

  • USA: GUDID submission deadline extended for device constituents of co-packaged combination products assigned to CDER

  • USA: Reclassification of single-use female condom and renaming as single-use internal condom

  • USA: Haemostatic device for intraluminal gastrointestinal use classified into Class II

  • USA: Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel classified into Class II

  • USA: Class II classification for the positive airway pressure delivery system

  • USA: Intranasal electrostimulation devices for dry eye symptoms classified into Class II (special controls)

  • USA: Class II classification for the thermal vestibular stimulator for headache

  • USA: External upper limb tremor stimulator becomes Class II (special controls)

  • USA: Class II classification for the light based energy source device for topical application

  • USA: Class I classification for the wound autofluorescence imaging device

  • USA: Proposed reclassification of ultrasound cyclodestructive devices

  • USA: Proposed list of accessories suitable for classification into Class I

  • USA: Paper/multiple copies of submissions could be replaced by electronic submissions

  • USA: Recommendations for labelling and safety testing of heparin-containing medical devices and combination products

  • USA: Benefit-risk factors to consider when determining substantial equivalence in 510(k) devices with different technological characteristics

  • USA: Guidance on appropriate use of voluntary consensus standards in pre-market submissions for medical devices

  • USA: Draft guidance on content of pre-market submissions for management of cybersecurity in medical devices

  • USA: Recognition and withdrawal of voluntary consensus standards addressed in draft guidance

  • USA: Eliminating routine FDA re-review of third party 510(k) reviews: formal plan and draft guidance

  • USA: Pilot programme to improve 510(k) review process for OCT devices

  • USA: Guidance on consideration of uncertainty in benefit-risk determinations for certain pre-market submissions

  • USA: Proposed expansion of the Special 510(k) Program

  • USA: Process for persons denied a Certificate to Foreign Government for a device is clarified in draft guidance

  • USA: Pre-market submission recommendations drafted for peripheral vascular atherectomy devices

  • USA: Comment period reopened for draft guidances on coronary drug-eluting stents

  • USA: CDRH publishes proposed guidance development lists for fiscal year 2019

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