North America - May 2020

  • Canada: New fees came into force on 1 April 2020

  • USA: Ban on electrical stimulation devices used for self-injurious or aggressive behaviour

  • USA: Class II classification for HIV drug resistance genotyping assays using next generation sequencing technology

  • USA: HIV serological/nucleic acid diagnostic and supplemental tests to be classified into Class II (special controls)

  • USA: Certain hepatitis C virus antibody assays proposed for reclassification into Class II

  • USA: Proposed reclassification of nucleic acid-based HCV RNA assay devices

  • USA: Criteria used to establish device eligibility in 3P510k Review Program are subject of new guidance

  • USA: Developing and labelling in vitro companion diagnostics for a specific group of oncology therapeutic products

  • USA: Final guidance released on non-binding feedback after certain FDA device establishment inspections

  • USA: Guidance on 510(k) submissions for peripheral vascular atherectomy devices

  • USA: Revised guidance on preparing 510(k) submissions for electrosurgical devices for general surgery

  • USA: Recommendations for bone anchor 510(k) submissions clarified in final guidance

  • USA: Guidance released on requests for appeals of significant decisions

  • USA: Performance criteria drafted for soft (hydrophilic) daily wear contact lenses

  • USA: Guidance drafted on arthroscopy pump tubing sets intended for multiple patient use

  • USA: Proposed labelling changes for laparoscopic power morcellators

  • USA: Response due dates for marketing applications are extended by 60 days

  • USA: FDA launches voluntary eSTAR Pilot to improve 510(k) submissions and reviews

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

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