Canada – Notice on Health Canada’s proposed changes to the guidance on recognized standards...
About the updates
Health Canada has updated the:
List of recognized standards for medical devices and
Guidance on using standards to support compliance with the Medical...
USA – FDA finalizes which clinical decision software functions it regulates
The US Food and Drug Administration (FDA) announced that it has finalized guidance on which clinical decision software (CDS) functions it regulates as a...
USA – FDA: Nearly 700 breakthrough medical device designations since 2015
The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review...
USA – FDA Clears First COVID-19 Home Antigen Test
Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home...
USA – FDA classifies slew of class II devices following de novo procedures
Since the last week of 2022, the US Food and Drug Administration (FDA) announced it was classifying nine products as class II devices with...
USA – Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder
The opioid epidemic is a serious and complex public health emergency facing the United States. The Agency has already taken significant steps to decrease...
USA – Device cybersecurity must be a priority from design through retirement, experts say
Cybersecurity must be a priority for any medical device that connects to the internet, from its earliest design phase to the end of its...
USA – FDA finalizes rule for over-the-counter hearing aid devices
The US Food and Drug Administration has finalized rules establishing over-the-counter (OTC) availability for certain types of hearing aids in order to improve public...
USA – US FDA sets some steep increases for 2023 medical device user fees
The US Food and Drug Administration announced that it has set medical device user fees for fiscal year 2023. Medical device manufacturers and importers seeking...
USA – Considerations for the Conduct of Clinical Trials of Medical Products During Major...
This guidance recommends approaches that sponsors of clinical trials of medical products can consider when there is a major disruption to clinical trial conduct...
