In 2013, FDA Commissioner Margaret Hamburg announced that the agency was looking to establish a risk-based framework for regulating lab-developed tests (LDTs) and released a draft guidance document to ...

The current European legislation for in vitro diagnostic medical devices (IVD) (Regulation 2017/746 or the IVDR) has created challenges not only for IVD manufacturers but also for pharmaceutical ...

In vitro diagnostics (IVD) companies today are facing a number of challenges related to FDA regulation of their products and tests. And many of these challenges can be summed up with just one word: ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Medical device regulators launched new initiatives on harmonizing in vitro diagnostic (IVD) regulations and tweaking the Medical Device Single Review Program (MDSAP) for additional countries to ...

Historically, pharmaceutical and diagnostic companies in the U.S. have inhabited parallel regulatory universes. Although both sets of firms are overseen by the FDA and are subject to some identical ...

Research assistant Nicole Gebert contributed to this article. Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition ...

insights from industryLaura NeaVP of Quality and Regulatory ManagementTecan In this interview, News-Medical talks to Laura Nea, Vice President of Quality and Regulatory Management at Tecan, about the ...

The EU’s Medical Device Regulation is now in full implementation mode, but the In Vitro Diagnostic Regulation (IVDR) won’t kick in until May 2022. Oliver Bisazza, director general of Medtech Europe, ...

Australia’s Therapeutic Goods Administration (TGA) issued a consultation paper on Tuesday to propose a new framework for the regulation of companion in vitro diagnostic (IVD) devices. The framework ...