Medical device and pharmaceutical industry groups in the EU and US are urging significant changes to the EU@s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Europe@s ...

Clinical performance data for medical devices with artificial intelligence (AI) features is often unavailable, making it difficult to assess real-world outcomes and potentially jeopardizing safety, ...

The regulatory environment of FSMPs in the EU has been previously well-described by Bushell. 61 The authors show the definition of FSMPS is broad enough to encompass a wide variety of FSMPs necessary ...

The Department of Government Efficiency (DOGE) this week claimed it had canceled 30 leases for US Food and Drug Administration (FDA) facilities nationwide, including a facility in St. Louis, MO, which ...

A US Food and Drug Administration (FDA) panel convened on Monday to explore the impact of selective serotonin reuptake inhibitors (SSRIs) on fetal development, with some panel members proposing that ...

This two-part article covers the specific requirements for placing foods for special medical purposes (FSMPs) on the market in major jurisdictions @ EU, UK, US, China, and other regions of the world @ ...

The US Food and Drug Administration (FDA) will only conduct vital and mission critical activities amid a government shutdown that began Wednesday after Congress failed to reach a deal to fund the ...

This event focuses on two key areas in MedTech: the distinction between wellness and regulated health technologies, and the integration of artificial intelligence throughout the product lifecycle.

The US Food and Drug Administration (FDA) finalized a rule allowing Institutional Review Boards (IRBs) to waive or alter elements of informed consent for certain clinical trials that pose minimal risk ...

This article reviews the changes in China@s national food safety control system and update on national food safety standard system and describes the country@s unique regulations and requirements for ...

Health and Human Services (HHS) Secretary Robert Kennedy Jr. announced on Wednesday that the Emergency Use Authorizations (EUA) for all COVID-19 vaccines have been rescinded, coinciding with the ...

President Donald Trump@s order requiring the removal of 10 regulations, rules, or guidances for each new one issued will put administrative pressure the US Food and Drug Administration (FDA) and other ...