Katrina’s Blog™
Insightful News and Commentary
On leadership, product innovation, talent cultivation, and ecosystem development across drugs, devices, diagnostics, and digital health tools.
Join us as we explore the latest trends and share expert insights to help you navigate the ever-evolving landscape of healthcare innovation.
Let’s embark on this journey of transformation together!
What are the Least Burdensome Approach for Medical Devices?
CDRH hosted a webinar on March 14th to review the current state of the Least Burdensome approach following issuance of an updated final guidance on February 5, 2019. The purpose of the approach is the remove or reduce unnecessary burden during the regulatory process...
Updates to the FDA’s Web Page May Mean Broken Links in Posts
I’ve recently noticed some updates to the FDAs web pages that may mean some broken links in my previous posts. When you click on some links, you will see the notification shown above (see an example by clicking here). I’ve been able to find the resources by copying...
CDRH forms the Office of Product Evaluation and Quality
Readers will recall my previous post on the reorganization of CDRH to create a more adaptive structure to meet future needs. As part of that reorganization, the Office of Product Evaluation and Quality (OPEQ) was launched on May 1st, 2019 (see the announcement here)....
The Life Science Innovation Northwest Conference
Medical Products in the NorthwestLast week’s Life Science Innovation Northwest conference offered a diverse look at the research and commercialization of medical products (both pharmaceuticals and medical devices) currently underway in the Pacific Northwest. Attendees...
MDEpiNet and the Women’s Health Coordinated Registry Network
One goal of the FDA’s Medical Device Safety Action Plan (see my previous post on the plan) is to support an improved national medical device evaluation and surveillance system. The Medical Device Epidemiology Network (MDEpiNet) is a public-private partnership...