This article highlights some of the similarities and differences between the Medical Device 510(k) and CE Marking regulatory pathways and helps harmonise some aspects...
As we eagerly anticipate the 14th China International Medical Device Regulatory Forum (CIMDR) from March 30 to April 4, 2024, we find ourselves reflecting...
The new article provides an overview of the new guidance document dedicated to the processes and procedures associated with the review of certain regulatory...
The FDA released a new draft 510k predicate selection guidance on September 7, but the draft guidance proposes controversial additions.
On September 7, 2023, a...
In April 2023, FDA published a new draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device...
The ‘‘Consolidated Appropriations Act, 2023’’ (H.R. 2617) was passed by the U.S. Senate and signed into law by President Biden on December 29, 2022....
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How pharmaceutical brands can use a multi-party, multi-tier network to achieve operational excellence and combat the competition
In...