Canada: Changes to evidence requirements for Class II and Class III infusion pumps
Canada: Applications for medical device Investigational Testing Authorisations (ITAs)
Canada: Use of Regulatory Enrolment Process using the Common Electronic Submission Gateway to be piloted for medical devices; ToC format to be adopted
Canada: Pilot project to formalise a framework for offering regulatory advice to device manufacturers to be launched
Canada: Guidance on 3D printed devices in development
Canada: Proposed changes to the List of Recognised Standards for medical devices
USA: FDA medical device user fees for Fiscal Year 2019
USA: Voluntary Malfunction Summary Reporting Program to streamline malfunction reporting for certain devices
USA: GUDID submission deadline extended for device constituents of co-packaged combination products assigned to CDER
USA: Reclassification of single-use female condom and renaming as single-use internal condom
USA: Haemostatic device for intraluminal gastrointestinal use classified into Class II
USA: Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel classified into Class II
USA: Class II classification for the positive airway pressure delivery system
USA: Intranasal electrostimulation devices for dry eye symptoms classified into Class II (special controls)
USA: Class II classification for the thermal vestibular stimulator for headache
USA: External upper limb tremor stimulator becomes Class II (special controls)
USA: Class II classification for the light based energy source device for topical application
USA: Class I classification for the wound autofluorescence imaging device
USA: Proposed reclassification of ultrasound cyclodestructive devices
USA: Proposed list of accessories suitable for classification into Class I
USA: Paper/multiple copies of submissions could be replaced by electronic submissions
USA: Recommendations for labelling and safety testing of heparin-containing medical devices and combination products
USA: Benefit-risk factors to consider when determining substantial equivalence in 510(k) devices with different technological characteristics
USA: Guidance on appropriate use of voluntary consensus standards in pre-market submissions for medical devices
USA: Draft guidance on content of pre-market submissions for management of cybersecurity in medical devices
USA: Recognition and withdrawal of voluntary consensus standards addressed in draft guidance
USA: Eliminating routine FDA re-review of third party 510(k) reviews: formal plan and draft guidance
USA: Pilot programme to improve 510(k) review process for OCT devices
USA: Guidance on consideration of uncertainty in benefit-risk determinations for certain pre-market submissions
USA: Proposed expansion of the Special 510(k) Program
USA: Process for persons denied a Certificate to Foreign Government for a device is clarified in draft guidance
USA: Pre-market submission recommendations drafted for peripheral vascular atherectomy devices
USA: Comment period reopened for draft guidances on coronary drug-eluting stents
USA: CDRH publishes proposed guidance development lists for fiscal year 2019
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