North America - Feb 2021
Canada: Revised fees for medical device applications become effective on 1 April 2021
Canada: Changes to post-market surveillance requirements for medical devices
Canada: Proposed extension of regulatory flexibilities for clinical trials of devices used to diagnose, treat, mitigate, or prevent COVID-19
Canada: Proposed changes to the List of Recognised Standards for medical devices
USA: Dr. Woodcock, former head of CDER, named as Acting FDA Commissioner
USA: More Class I devices exempt from 510(k) requirements and Class II/unclassified devices proposed for exemption
USA: FDA releases artificial intelligence/machine learning action plan
USA: Updated product labelling recommendations for laparoscopic power morcellators
USA: Guidance on regulatory considerations for microneedling products
USA: Safer Technologies Program outlined in new final guidance
USA: Device-specific performance criteria set out in new final guidance documents
USA: Obtaining feedback from the FDA on combination products discussed in new guidance
USA: Guidance issued on conducting mouse embryo assays for assisted reproduction technology devices
USA: Technical considerations drafted for demonstrating EMC of medical devices
USA: Compliance date extended for necessary AED accessories
USA: Latest medical device guidance issued in relation to COVID-19
USA: FDA implements certification for devices not exported from the USA
USA: Progress tracker for pre-market submissions in development
USA: FDA updates recognised consensus standards database
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