USA – Diversity plan draft guidance on track before year end, FDA official says
The US Food and Drug Administration (FDA) is on track to publish a draft guidance on diversity plans before year’s end, which will take...
USA – Convergence: Tips for when to include PCCPs in product submissions
The US Food and Drug Administration (FDA) sees predetermined change control plans (PCCPs) as a way to improve medical device innovation in the country,...
USA – The biggest misconception regulatory professionals have about the FDA 510(k) program, according...
The 510(k) program is the most common pathway through which medical devices make their way to market in the US.
For devices that can demonstrate...
Europe – Convergence: MDR timeline extension is smoothing transition, but concerns persist
The European Union’s Medical Device Regulation (MDR) timeline extension has addressed some of the issues manufacturers raised with the transition period but the process...
USA – FDA updates physiologic closed-loop control final guidance with industry feedback
The US Food and Drug Administration (FDA) has finalized guidance on physiologic closed-loop control (PCLC) technologies that includes several updates requested by medical device...
USA – FDA guidance explores trial design, supporting data for GVHD treatments
In preparation for a potential “paradigm shift” in the management of graft-versus-host disease (GVHD), the US Food and Drug Administration (FDA) is seeking comment...
USA – FDA revises final guidance on modifying remote monitoring devices
The US Food and Drug Administration (FDA) has updated final guidance on its enforcement policy for remote patient monitoring devices in an effort to...
Europe – In vitro diagnostic device regulation in Europe: Update on revisions
The transition from complying with the EU IVDD 98/79/EC to meeting the requirements of the new EU IVDR 2017/746 involves a substantial regulatory framework...
Europe – MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations
Software has become an increasingly important part of the medical device landscape. It is
estimated that one in four medical devices either incorporate medical device...
Europe – Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device...
Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002...
