Resource Centre
Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.
-
Predetermined Change Control Plans (PCCPs) Draft Guidance with Implications for Medical Device Manufacturers and regulatory framework
-
The U.S. Food and Drug Administration (FDA) made a significant update to its regulatory approach for in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs). Detailed in a FDA Laboratory Developed Tests Policy guidance document issued on June 25, 2024.
-
Gender data gap’s implications on women’s health and strategic measures for its integration into gender gap medical devices, regulatory frameworks and design processes.
-
FDA Real-World Evidence Draft Guidance analysis identifies five key points to help understand the potential impact of the draft guidance.
-
Analysis of FDA draft guidance “Decentralized Clinical Trials for Drugs, Biological Products, and Devices.”
-
Overview of eSTAR, a joint Health Canada and FDA program streamlining medical device submissions with info on how to apply for the program.
-
Review of the FDA transition plan for medical devices currently marketed under Emergency Use Authorizations with implications for devices.
-
How the FDA Catalog of Regulatory Science Tools can reduce risk in medical devices and explores several tools and categories.
-
FDA Approved or Cleared Medical Device – the pathway you choose depends on the level of risk it represents and its intended use.
