Becker's Hospital Review

Unique device identifiers required for class II medical devices this fall

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 ...
RAPS

FDA classifies slew of class II devices following de novo procedures

Since the last week of 2022, the US Food and Drug Administration (FDA) announced it was classifying nine products as class II devices with special controls. The list of devices includes several ...
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 ...