USA – FDA names new head of medical device evaluation and quality

The Food and Drug Administration named Ross Segan as director of the medical device center’s Office of Product Evaluation and Quality (OPEQ), following a...

USA – FDA releases three post-pilot ASCA draft guidances

The US Food and Drug Administration (FDA) has issued its first set of draft guidance documents for the full-fledged Accreditation Scheme for Conformity Assessment...

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The US Food and Drug Administration (FDA) on Thursday issued a draft guidance that would significantly revise its previous guidance on using voluntary patient...
Statement on the Investigational Use of Marketed Drugs in Clinical Trials

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,...
Coronavirus delays many FDA foreign inspections

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...

NOS PROCHAINES FORMATIONS