News Medical

Medical Device Categories Explained

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 ...
RAPS

FDA Moves Three Device Types into Class II Special Controls

The US Food and Drug Administration (FDA) has proposed classifying three types of medical device products into its Class II regulatory controls scheme, subjecting them to special controls meant to ...
RAPS

FDA exempts additional Class II devices from 510(k) requirements

The US Food and Drug Administration (FDA) on Tuesday finalized an order to exempt five types of Class II medical devices from 510(k) requirements, which the agency says will decrease regulatory ...
Agence France-Presse

Fujirebio Expands Access in Canada to Blood-based Neurology Testing with Health Canada Class II Medical Device Licenses for the Lumipulse® G NfL Blood and Lumipulse G pTau 217 ...

H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that Health Canada has issued Class II Medical Device Licenses (MDL) for the Lumipulse G NfL Blood and the Lumipulse ...