North America - December 2017

  • Canada: Comments solicited on proposed new fees for medical devices and pharmaceuticals

  • USA: Key provisions of the ‘FDA Reauthorization Act of 2017’ relating to medical devices

  • USA: High intensity ultrasound systems for prostate tissue ablation classified into Class II

  • USA: Class II classification for the closed loop hysteroscopic insufflator with cutter-coagulator

  • USA: Cranial motion measurement device classified into Class II and special controls established

  • USA: Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid classified into Class II

  • USA: Class II classification for the organophosphate test system

  • USA: Enzyme packed cartridge classified into Class II and special controls identified

  • USA: Nucleic acid-based device for the amplification, detection and identification of microbial pathogens directly from whole blood deemed to be Class II

  • USA: Classification of the automated image assessment system for microbial colonies on solid culture media as Class II

  • USA: Oral removable palatal space occupying device for weight management and/or weight loss classified into Class II

  • USA: Class II classification for the zinc transporter 8 autoantibody immunological test system

  • USA: Mass spectrometer system for clinical use for the identification of microorganisms classified into Class II

  • USA: Class II classification for the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis

  • USA: Adjunctive cardiovascular status indicator classified into Class II (special controls)

  • USA: Class II classification for the balloon aortic valvuloplasty catheter

  • USA: Quality control material for clinical microbiology assays classified into Class II (special controls)

  • USA: Software pre-certification pilot programme launched

  • USA: Guidance issued on qualification of Medical Device Development Tools (MDDT)

  • USA: Guidance to assist in preparation of a 510(k) for a diagnostic radiology display device

  • USA: Guidance published on use of real-world evidence to support regulatory decision-making

  • USA: Design considerations and pre-market submission recommendations for interoperable medical devices

  • USA: New guidance clarifies procedures for classification of products as drugs or devices

  • USA: Guidance on establishing performance characteristics of IVDs for the detection, or detection and differentiation, of HPVs

  • USA: New guidance issued on the evaluation and reporting of age, race and ethnicity data in medical device clinical studies

  • USA: Marketing clearance of diagnostic ultrasound systems and transducers addressed in new draft guidance

  • USA: Initial recommendations drafted on utilising animal studies to evaluate organ preservation devices

  • USA: Regulatory considerations are drafted for microneedling devices

  • USA: Guidance drafted on policy clarification and 510(k) submissions for ultrasonic diathermy devices

  • USA: ‘Premarket Approval Application Critical to Quality’ voluntary pilot programme launched

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

  • USA: Process for recognising voluntary consensus standards updated and clarified

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