freedommagOpinion

Electroshock Devices Remain in FDA’s Class II Category Despite Reports of Brain Injury and Death

Jose Topete’s family says 23 electroshock treatments left him unable to recognize his wife and children, remember the life he ...
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 ...
Business Wire

Tasso+™ Device Earns FDA 510(k) Class II Medical Device Clearance

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 ...
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 ...
Nature

Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA’s De Novo pathway

Medical devices have played a critical role in raising the standards of healthcare delivery. The COVID-19 pandemic underscored clinical medicine’s dependence on devices ranging from diagnostic test ...
Medical Device and Diagnostic Industry (MD+DI)

FDA Issues First Update to 510(k) Exemption Guidance Since 2019

FDA adds five product codes to its premarket notification exemption list, expanding 510(k) exemptions for certain low-risk class I and II devices.