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 ...

Starting in September, class II medical devices will be required to be equipped with a unique device identifier to be in compliance with UDI regulations. The U.S. Food and Drug Administration passed ...

Roche Diagnostics is the first manufacturer to score certification for a class D product under the new in vitro diagnostic regulation (IVDR). TÜV SÜD Product Service issued the IVDR certificate. TÜV ...

SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of convenient, clinical-grade blood collection solutions, today announced that the U.S. Food and Drug Administration (FDA) has cleared its ...

Following the temporary lapse in FDA inspections of manufacturing sites amid the COVID-19 pandemic, this year has already seen more class I medical device recalls issued than in all of 2020. The ...

At MD&M West 2026, Carl Douglass cuts through the hype to show how additive manufacturing truly accelerates Class II and III ...

Minneapolis-based Smiths Medical recalled nearly 20 million medical devices after two deaths, 25 injuries and 10,672 incidents were reported, the FDA said Feb. 2. In a Class I recall — the most ...