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 ...
Medical Device Network on MSN
LifeVac receives FDA De Novo classification for anti-choking device
LifeVac is approved for use as a single-use, non-powered, non-invasive airway clearance device.
Healthcare Asia Magazine on MSN
Singapore clinches WHO’s top medical device classification
International experts validate Singapore device regulation system. Singapore's Health Sciences Authority (HSA) reached Maturity Level 4 (ML4) for medical device regulation, making it the first World ...
Stratasys believes the CE marking will enable broader clinical use and expand patient access to 3D printed dentures, crowns, ...
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 ...
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 ...
The designation follows an extensive assessment using the WHO Global Benchmarking Tool Plus for Medical Devices (GBT+MD).
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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