Europe – The European Medical Technology in Figures 2023
Capturing the activity of the medical technology industry is vital for healthcare stakeholders, business leaders and policymakers.
Updated regularly, this platform draws on data from...
USA – FDA revises magnetic resonance guidance to reflect updated international standard
The US Food and Drug Administration (FDA) has revised its position on magnetic resonance (MR) with updates to a pair of final guidance documents.
One...
USA – FDA’s CDRH releases list of proposed guidances for FY 2024
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has named the guidance documents it plans to publish during Fiscal...
USA – Diversity plan draft guidance on track before year end, FDA official says
The US Food and Drug Administration (FDA) is on track to publish a draft guidance on diversity plans before year’s end, which will take...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 – New guidances outline eSTAR submission requirements for de novo and 510(k) device...
The US Food and Drug Administration is one step closer to requiring electronic submission of all premarket applications for both 510(k) and de novo...
