USA – Diversity plan draft guidance on track before year end, FDA official says
The US Food and Drug Administration (FDA) is on track to publish a draft guidance on diversity plans before year’s end, which will take...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...
USA – FDA proposes long-awaited LDT enforcement rule
The US Food and Drug Administration (FDA) has published a much-anticipated proposed rule that aims to end its enforcement discretion of laboratory-developed tests (LDT)...
USA – FDA premarket cybersecurity guidance clarifies SBOM requirements
The US Food and Drug Administration (FDA) has published a premarket cybersecurity guidance almost a decade in the making. The document adds requirements based...
Euro Roundup: Pharma reform could cause loss of 3 new orphan drugs a year,...
The European Commission’s plan to reform pharmaceutical legislation could cause three fewer rare disease drugs to come to market each year, according to a...
