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...
Talk about the fundamental changes coming to European medical device regulation has been buzzing through the industry for the past several years. Medical device firms across the globe have been preparing themselves for changes to their regulatory compliance strategies...
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. ...
The Medical Device Single Audit Program (MDSAP) has been a blessing for many medical device manufacturers because it has allowed third-party auditors to conduct a single audit of a medical device company to satisfy the regulatory requirements of the five countries...
In less than 430 days, the In Vitro Diagnostic Regulation will fully replace the EU’s current Directive on in vitro diagnostic medical devices (IVDD 98/79/EC). Are you prepared for the transition? What is In Vitro Diagnostic Regulation (IVDR)? The IVDR is the new...
While telehealth technology and its use are not new, trends show some increased interest in the use of telehealth services by both healthcare professionals (HCP) and patients. Due to the COVID-19 pandemic, changes in the way that healthcare is delivered are being...
It should come as no surprise that the far-reaching effects of the COVID-19 pandemic include how notified bodies are conducting audits of medical device manufacturers. The European Commission’s Medical Device Coordination Group (MDCG) recently released a document...
In the Trump Administration’s final days, the Department of Health and Human Services (HHS) has changed the US Food and Drug Administration’s (FDA) regulatory oversight policies. The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule would force...
White Paper on Transition Plan for Medical Devices that fall within enforcement policies and EUAs issued during the COVID-19 Public Health Emergency. The FDA has provided their thoughts on 180-day transition plans to get back to standard practices (compliance with the...
With everything from cars to pacemakers now susceptible to cyberattack, questions about how safe our data is have come to the forefront. The Food and Drug Administration (FDA) is one of the organizations taking these concerns seriously, working to ensure that medical...
If you are a medical device manufacturer, it is crucial to have the necessary recall policies and procedures in place to handle a potential field action quickly and effectively. A product recall can be costly and damaging to a company's reputation, so it's essential...
