The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the classification of products under the Medical Device Regulation (MDR) and the In Vitro ...
The US Food and Drug Administration (FDA) announced its intent on Thursday to exempt certain unclassified medical devices ...
The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...
FDA's Center for Devices and Radiological Health (CDRH) issued a request for public comment on December 5, 2025, seeking feedback on the distinct classification of existing medical device accessories ...
To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min In a warning letter dated Sept ...
Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...
LifeVac has received De Novo classification from the US Food and Drug Administration (FDA) for its suction anti-choking device under 21 Code of Federal Regulations (CFR) 874.5400. The authorisation ...
Medical Device Network on MSN
Podcast: Assessing the EMA’s new innovative medical device pathway pilot
A key component of the EMA's innovative device pathway is to offer expert support to manufacturers of breakthrough medical ...
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