Canada: Further reductions to MDSAP audit durations have been announced for small companies
Canada: Health Canada is adopting the Global Medical Device Nomenclature (GMDN)
Canada: Down classification of artificial larynx devices into Class I
Canada: Comments sought on Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting – Hospitals)
USA: Next generation sequencing based tumour profiling test is classified into Class II
USA: Class II classification for the brain trauma assessment test
USA: Fluid jet system for prostate tissue removal classified into Class II and subject to a 510(k)
USA: Class II classification assigned to the endoscopic electrosurgical clip cutting system
USA: In vivo cured intramedullary fixation rod classified as Class II
USA: Microneedling device for aesthetic use classified into Class II
USA: Class II classification for blood establishment computer software (BECS) and its accessories
USA: Sharps needle destruction devices down-classified into Class II
USA: Exemption from pre-market notification for five types of Class II medical devices
USA: Certain Class II surgical apparel now exempt from pre-market notification
USA: Changes proposed to update the product jurisdiction regulations
USA: Proposed reclassification of medical image analysers from Class III to Class II
USA: Alternative or streamlined mechanisms for complying with the cGMP requirements for combination products
USA: Medical product communications that are consistent with the FDA-required labelling; guidance for industry
USA: Logical observation identifiers names and codes (LOINC) for IVD tests
USA: Updated guidance drafted on the Q-Submission programme
USA: Consultation underway on draft guidance concerning 510(k) submissions for metal expandable biliary stents
USA: Guidance drafted on recommended content and format of complete test reports for non-clinical bench performance testing
USA: Draft guidance issued on the policy and considerations for multiple function device products
USA: Draft guidance documents on recommended pre-market testing and labelling for intravascular catheters, guidewires and delivery systems
USA: Common questions on the HDE programme addressed in new draft guidance
USA: Quality System Regulation to be aligned with ISO 13485:2016
USA: ‘Innovation challenge’ launched to support development of novel medical devices to help combat the opioid crisis
USA: Modifications to the list of US FDA-recognised standards
Click here for the full article on Global Regulatory Press.
Contact us at info@arqon.com.