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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