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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