Manufacturers, Medical Device Data System

EU: In Vitro Diagnostic Regulation Entered Into Force (Part 3 Of 3)

MoFo Life Sciences on 6/14/2022

Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more

FDA Names First Acting Director Of Medical Device Cybersecurity

Jackson Lewis P.C. on 2/24/2021

The U.S. Food and Drug Administration (FDA) named University of Michigan Associate Professor Kevin Fu Acting Director of Medical Device Security in its Center for Devices and Radiological Health. This is a newly created...more

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

Hogan Lovells on 6/12/2017

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device...more

Medical Device Updates: U.S. Food and Drug Administration (FDA) Practice Trends

Mintz on 7/9/2016

Data and Analytics — FDA’s Post-market Surveillance Data Proposals Press Forward - FDA’s National Evaluation System for Health Technology, or NEST, as FDA calls it, is quickly gaining traction as one of the...more

FDA Outlines Future Medical Device Coordinating Center

Foley & Lardner LLP on 5/13/2016

The federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to...more

What’s an MDDS? And Why Should I Care?

Faegre Drinker Biddle & Reath LLP on 8/1/2014

Last month the Food & Drug Administration (FDA) announced still further relaxation of its oversight over anything qualifying as a “medical device data system,” or MDDS. The announcement should come as welcome news to a great...more