In five separate consultations opened on Wednesday, Australia’s Therapeutic Goods Administration (TGA) proposed new medical device classifications in line with the EU medical device regulation (MDR).

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...