USA – Final FDA guidance on PCCP includes clarification on version control
The US Food and Drug Administration (FDA) has finalized a long-anticipated guidance on using predetermined change control plans (PCCPs) in submissions for medical devices...
USA – FDA finalizes guidance on 510(k) third-party reviews
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance to assist manufacturers in using an...
USA – The regulatory landscape of ingestible medical devices in the United States
Ingestible medical devices offer novel diagnostic, monitoring, and treatment capabilities. This article explores the regulatory landscape of ingestible devices in the US, highlighting the...
USA – Data Normalization Challenges and Mitigations in Software Bill of Materials (SBOM) Processing:...
The Mitre Corporation says stakeholders should work together to normalize how software bill of materials (SBOMs) are implemented in a newly published white paper,...
Canada – Health Canada digital health head says AI/ML guidance imminent
Health Canada is very close to publishing a much-anticipated guidance on artificial intelligence/machine learning (AI/ML) medical devices and has incorporated pre-determined change control plans...
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The US Food and Drug Administration (FDA) has issued its first set of draft guidance documents for the full-fledged Accreditation Scheme for Conformity Assessment...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...
