North America - April 2017

  • Canada: Non-eCTD electronic-only format to be used for medical device regulatory activities

  • Canada: Scientific and clinical content of licence applications for dermal fillers set out in new guidance document

  • Canada: List of recognised standards for medical devices has been updated

  • USA: 21st Century Cures Act signed into law

  • USA: Most powdered medical gloves are now banned in the USA

  • USA: Pedicle screw systems, including semi-rigid systems, are renamed and reclassified

  • USA: Computerised cognitive assessment aids for concussion have been classified into Class II (special controls)

  • USA: Class II classification deemed appropriate for the Eustachian tube balloon dilation system

  • USA: Paediatric hospital beds are renamed paediatric medical cribs; separate classification created for medical bassinets; special controls established

  • USA: Neurovascular mechanical thrombectomy device for acute ischaemic stroke treatment classified into Class II

  • USA: Up-classification of specialised surgical instrumentation for use with urogynaecologic surgical mesh

  • USA: Reclassification of certain microbiology devices and designation of special controls

  • USA: Post-marketing safety reporting requirements for combination products

  • USA: Determining when a tobacco product is a drug, device or combination product

  • USA: New import data requirements for FDA-regulated products

  • USA: Post-market management of cybersecurity in medical devices

  • USA: Risk:benefit factors to consider in compliance and enforcement decisions

  • USA: Factors to consider when making benefit:risk determinations for IDEs

  • USA: Public notification of emerging post-market medical device signals

  • USA: Labelling for permanent, hysteroscopically-placed tubal implants for sterilisation

  • USA: Guidance published on pre-market notification submissions for Magnetic Resonance Diagnostic Devices

  • USA: Mitigating the risk of cross-contamination from the use of flexible gastrointestinal endoscopes

  • USA: Clinical considerations for neurological devices targeting disease progression and clinical outcomes

  • USA: Guidance published on the regulation of accessories to medical devices

  • USA: Updated guidance for manufacturers on Medical Device Reporting

  • USA: FDA relaxes certain conditions for sale for air-conduction hearing aids

  • USA: cGMP requirements for combination products - supplemental guidance published

  • USA: Guidance published for IRBs, investigators and sponsors on the use of electronic informed consent

  • USA: Q&A on medical product communications that are consistent with FDA-required labelling

  • USA: Clarification drafted on acceptable manufacturer communications with payors, formulary committees and similar entities

  • USA: Advice is drafted on how to prepare a Pre-Request for Designation (Pre-RFD)

  • USA: Addition of safety statement proposed for product labelling of certain ultrasonic surgical aspirator devices

  • USA: Comments solicited on proposed recommendations for bone anchor 510(k) submissions

  • USA: FDA and CMS Parallel Review programme to continue

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

  • USA: CDRH publishes proposed guidance development lists for fiscal year 2017

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