North America - February 2018

  • Canada: Introduction of reduced MDSAP audit times

  • Canada: Regulations affecting dental x-ray equipment have been amended

  • Canada: Proposed amendment of rules concerning disclosure of information from clinical studies or investigational testing

  • Canada: Guidance issued for manufacturers of HIV RDTs for use at the point of care or for self-testing

  • Canada: Guidance drafted on applications for medical device Investigational Testing Authorisations (ITAs)

  • Canada: Scope of the Regulatory Enrolment Process using the Common Electronic Submission Gateway may be expanded to include medical devices

  • USA: Controversial medical device excise tax suspended for another two years

  • USA: Classification of the external negative pressure airway aid into Class II

  • USA: Class II classification for the image processing device for estimation of external blood loss

  • USA: Pressure wedge for the reduction of caesarean delivery classified into Class II

  • USA: Class II classification for the external vagal nerve stimulator for headache

  • USA: Special controls established for rectal balloon for prostate immobilisation as part of Class II classification

  • USA: FDA classifies flow cytometric test system for haematopoietic neoplasms into Class II

  • USA: Computerised behavioural therapy device for psychiatric disorders has been classified into Class II (special controls)

  • USA: Irrigating wound retractor device classified into Class II

  • USA: Class II classification and special controls for the whole slide imaging system

  • USA: Class II classification is deemed appropriate for the foetal head elevator

  • USA: Tear electrostimulation devices are classified into Class II

  • USA: Class II special controls established for the genetic health risk assessment system

  • USA: Class II classification for the non-EEG physiological signal based seizure monitoring system

  • USA: Automated indirect immunofluorescence microscope and software-assisted system receives Class II designation

  • USA: Total 25-hydroxyvitamin D mass spectrometry test system has been classified into Class II (special controls)

  • USA: Newborn screening test for SCID becomes Class II following a de novo request

  • USA: Classification of the Aquaporin-4 autoantibody immunological test system into Class II

  • USA: Class II classification for the acute kidney injury test system

  • USA: Class II classification deemed appropriate for the Streptococcus spp nucleic acid-based assay

  • USA: BCR-ABL quantitation test classified into Class II

  • USA: Class II classification for the prostatic artery embolisation device

  • USA: Absorbable perirectal spacer receives Class II assignment

  • USA: Class II classification for the cervical intraepithelial neoplasia (CIN) test system

  • USA: Class I classification deemed appropriate for reagents for molecular diagnostic instrument test systems

  • USA: 510(k) exemption, subject to limitations, for autosomal recessive carrier screening gene mutation detection system devices

  • USA: Correction to the classification of the oral removable palatal space occupying device for weight management and/or weight loss

  • USA: Reclassification and renaming of single-use female condoms proposed

  • USA: Needle destruction devices to be renamed and reclassified under proposed order

  • USA: Proposed delay of effective date: when products made/derived from tobacco are regulated as drugs, devices or combination products; amendments to regulations regarding intended uses

  • USA: Certain Class II surgical apparel proposed for 510(k) exemption

  • USA: Proposed rule on the procedures for internal agency supervisory review of certain decisions made by the CDRH

  • USA: Guidance on when to submit a 510(k) for a change to an existing device

  • USA: Deciding when to submit a 510(k) for a software change to an existing device

  • USA: Final guidance released on the de novo classification process (evaluation of an automatic Class III designation)

  • USA: New guidance details UDI compliance policy for Class I and unclassified medical devices

  • USA: Guidance published on direct UDI marking of medical devices

  • USA: Updated guidance issued on medical device accessories and their classification

  • USA: Guidance on sharing patient-specific information from a medical device

  • USA: Technical considerations specific to devices using additive manufacturing (3D printing) are subject of new guidance

  • USA: FDA categorisation of IDE devices to assist the CMS with coverage decisions is the subject of new guidance

  • USA: Guidance issued on inclusion of paediatric information/labelling for X-ray imaging devices in pre-market notifications

  • USA: Labelling of certain ultrasonic surgical aspirator devices should include a specific safety statement

  • USA: Three new digital health policy documents unveiled

  • USA: Proposed expansion of the least burdensome provisions set out in new guidance

  • USA: Acceptance review policies for de novo classification requests drafted in the form of guidance

  • USA: Updates proposed to guidance on replacement reagent and instrument family policy for in vitrodiagnostic devices

  • USA: Draft guidance on IVDs used in clinical investigations of therapeutic products circulated for public comment

  • USA: Consultation has been held on draft guidance concerning implementation of the Breakthrough Devices Program

  • USA: Guidance drafted on the evaluation of devices used with Regenerative Medicine Advanced Therapies

  • USA: Public warning and notification of recalls discussed in new draft guidance

  • USA: Comments sought on draft guidance documents concerning CLIA waiver applications

  • USA: CDRH publishes proposed guidance development lists for fiscal year 2018

  • USA: eMDR adverse event codes to change in April 2018

  • USA: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program

  • USA: Voluntary Malfunction Summary Reporting Program proposed

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

Click here for the full article on Global Regulatory Press.

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