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Manufacturers Diagnostic Tests

Butler Snow LLP

Crafting a Measured Response to the Right-To-Repair Movement

Butler Snow LLP on

Over the last several years, State and Federal legislatures across the country have proposed and adopted laws that will transform and hinder the entire manufacturing industry. The various right-to-repair laws gaining traction...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Venable LLP

FDA Medical Device Updates to Emergency Use Authorizations and Enforcement Discretion Issued During the COVID-19 Public Health...

Venable LLP on

On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more

Latham & Watkins LLP

EU MDR Transitional Provisions Officially Extended

Latham & Watkins LLP on

The revised provisions provide medical device and in-vitro diagnostics manufacturers with additional time to bring their product into compliance with the new EU Regulations, subject to a number of conditions. On March 20,...more

MoFo Life Sciences

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

MoFo Life Sciences on

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

MoFo Life Sciences

EU: IN VITRO Diagnostic Regulation Entered Into Force (Part 1 OF 3)

MoFo Life Sciences on

In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the...more

Hogan Lovells

FDA updates FAQ on COVID-19 tests and validation

Hogan Lovells on

Last week, on 23-25 June 2020, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) updated the responses to six of the Frequently Asked Questions related to laboratories and...more

ArentFox Schiff

To Repair or Not to Repair Electronic Devices? More Right to Repair Laws on the Horizon

ArentFox Schiff on

Right to repair laws have come in and out of the public eye over the last decade. While many of the earliest laws covered only specific industries, such as the automotive and farm equipment industries, many states are looking...more

Knobbe Martens

EU Reaches Deal on New Medical Device Regulations

Knobbe Martens on

The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. ...more

Foley & Lardner LLP

Navigating the Diagnostic Commercialization Process

Foley & Lardner LLP on

Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

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