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 ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
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 ...
Hosted on MSN

US FDA medical device clearance demystified – what investors need to know

FDA classifies medical devices based on the type of device and the level of risk it poses Three main FDA clearances for medical devices are 510(k), de novo and pre-market approval Several ASX ...
FierceBiotech

GAO probe finds understaffed FDA putting some medical device recall work on the 'back burner'

The FDA’s oversight of medical device recalls continues to be plagued by staffing challenges—forcing some activities to be placed on the “back burner” and resulting in lengthy response times, ...