The US Food and Drug Administration (FDA) announced its intent on Thursday to exempt certain unclassified medical devices ...
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 ...
Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...
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 ...
Connected medical devices can improve patient care and operational efficiency. However, they also introduce new privacy and security risks. Healthcare providers should rethink their privacy and ...
FDA has finalized guidance on medical device classification product codes that are used to assist in accurate identification and tracking of current medical devices, and for easy reference to ...
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 ...
After enactment of the Medical Device Amendments of 1976, which established three regulatory classes for medical devices, the Food and Drug Administration (FDA) has been required to classify all ...
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 ...
In response to changes mandated by the 21st Century Cures Act to the legal definition of "device," the U.S. Food and Drug Administration has amended some of its classification regulations to exclude ...
A medical device is any appliance, apparatus, software, material, or other articles, which may be used in isolation or combination (as defined by the manufacturer) by individuals for a medical purpose ...
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