On October 10, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) published its annual list of guidance document priorities for the...
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The In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR) was released back in 2017 and represents one of the most impactful regulations ever...
A growing trend in the medical device industry has been the ongoing efforts by FDA to harmonize with international standards. The hope is that...
On August 22, 2024, the FDA issued a new draft guidance document titled “PredeterminedChange Control Plans for Medical Devices”. A Predetermined...
In August 2024, the FDA announced the release of final guidance titled “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.”...
On September 20, 2024, FDA released draft guidance titled “Chemical Analysis for Biocompatibility Assessment of Medical devices”. The guidance...
The distinction between “servicing” and “remanufacturing” has often caused confusion throughout the medical device industry. Consequently, earlier...
