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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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