The FDA's Digital Health Center of Excellence (DHCoE), founded in 2020, is a resource for both industry and the public, intending to accelerate innovation in digital health. Recently, they've been involved in several pilots and activities to promote digital health...
The European Union had recently proposed doing what the medical device industry has been urging for years – delaying the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR) that is slated to replace the current In Vitro...
If you are currently selling, or planning to sell, medical devices in the United Kingdom, the clock is ticking for Class III, IIb, IIa, and I devices. As of January 1, 2022, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has mandated that all...
The sobering image on the evening news of dozens of massive container ships waiting off the coast of California is all anyone needs to know about the state of the supply chain today. Nothing is moving. Medical device manufacturing is just one of the many industrial...
The CEO and CFO of SpineFrontier, a Malden, MA-based spinal device manufacturer, were recently indicted in connection with a kickback scheme to bribe surgeons to use their products in exchange for “consulting fees,” according to a statement released by US Attorney for...
The COVID-19 pandemic has made obscure regulatory procedures big news across the globe. Chief among these is the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) authority, the expedited pathway through which COVID-19 vaccines were authorized....
The healthcare industry can be full of tempting offers, many perfectly legal, though there are some that are not. To make matters more difficult, illegal ones can appear above-board and acceptable when, in fact, some aspects of them pose a significant legal risk to...
Growing numbers of medical devices are using artificial intelligence and its associated technology—machine learning—to diagnose patients more precisely and treat them more effectively. Although many devices have already been cleared by the FDA, many regulatory...
On May 26 the new Medical Device Regulation (MDR) will replace the previous Medical Device Directive (MDD).
The new European medical device database, known as Eudamed, was originally scheduled to launch in May 2020, but the pandemic caused its implementation to be delayed two years, until May 26, 2022. However, that does not mean that compliance considerations are on hold. ...