USA – FDA Authorizes First Over-the-Counter Hearing Aid Software
Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with...
USA – Industry groups call for changes to FDA’s guidance on use-related risk analyses
Stakeholders want the US Food and Drug Administration (FDA) to provide more clarity on its expectations for use-related risk analyses (URRA) for “stand-alone” non-combination...
Canada – The evolution of Canada’s medical device regulatory framework
The evolution of the medical device regulatory framework in Canada is not as well understood as those of other major jurisdictions such as the...
USA – FDA updates patient preference guidance to span the product life cycle
The US Food and Drug Administration (FDA) on Thursday issued a draft guidance that would significantly revise its previous guidance on using voluntary patient...
Canada – Notice on Health Canada’s proposed changes to the guidance on recognized standards...
Health Canada has updated the:
List of recognized standards for medical devices and
Guidance on using standards to support compliance with the Medical Device Regulations
The...
USA – FDA unveils FY 2025 user fee rates
The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2025 across its prescription drug, generic drug, biosimilar,...
USA – FDA finalizes COVID-era guidance on container closure changes
The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors in reporting common changes made to glass vials and stoppers,...
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 issues final guidance user fees for combination products
The US Food and Drug Administration (FDA) on Tuesday finalized guidance for sponsors explaining how it assesses user fees for combination products and the...
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...
