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 All These Device Review and Approval Pathways? Part 7
De NovoThe DeNovo Classification process has yet to be established in the regulations, though it was added to the FD&C Act in 1997 and further updated in subsequent amendments. A proposed rule for the DeNovo process was published in early December 2018 and will be...
Today is Rare Disease Day
The last day of February is designated Rare Disease Day, a campaign to raise awareness of rare diseases and their impact on patients, caregivers, and society. On this day local organizations host events to improve public knowledge of rare diseases and advocate for...
What Are All These Device Review and Approval Pathways? Part 6
Premarket ApprovalMost devices categorized as Class III (devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury) are required to go...
What Are All These Device Review and Approval Pathways? Part 5
Strengthening the 3rd Party 510(k) Review ProgramThe 3rd Party (3P) Review Program is an alternative process for manufacturers of medical devices to speed decisions on premarket applications for low- to moderate-risk and less complex medical devices. Under the program...
Draft Guidance on Rare Disease Drug Development
The CDER/CBER divisions of the FDA released a draft guidance in February 2019 describing various approaches to addressing challenges common in rare disease drug development. This latest guidance focuses on issues faced by sponsors in clinical trials; issues in early...