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 ...
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 ...
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 ...
Business Insider

ProSomnus® Receives FDA Class II Clearance for RPMO2 OSA Device

SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today ...
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 ...
American Hospital Association

CMS, FDA announce pathway to expedite access to certain medical devices for Medicare beneficiaries

The Centers for Medicare & Medicaid Services and the Food and Drug Administration April 23 announced a new pathway to ...
Becker's Hospital Review

1 month until all Class II devices must be labeled with UDIs

Starting September 24, the Food and Drug Administration will require all Class II devices to be labeled with unique device identifiers. The FDA introduced the unique device identifier system in 2013 ...
Becker's ASC

Trump administration to change coverage for breakthrough cardiology devices

CMS and the FDA have proposed a new coverage policy to change Medicare beneficiaries access to certain FDA-designated Class II and Class III breakthrough devices. According to an April 23 FDA news ...
JD Supra

Unpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?

It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is ...
Gizmochina

Xiaomi to launch its first Blood Pressure Smartwatch with Class II medical device certification on Oct 26

According to the teased image, this smartwatch will feature a round dial with a sleek, non-bulky design and two physical buttons on the right side. The strap seems sturdy and is expected to include ...