Gluten and Food Labeling: What You Need to Know
Gluten and Food Labeling: What You Need to Know
Discover That it is Possible to Import Dental Products.
Discover That it is Possible to Import Dental Products
“Discover the critical role that packaging plays in the development of cosmetic products.”
“Discover the critical role that packaging plays in the development of cosmetic products.”
Review of the Draft Technovigilance Standard by COFEPRIS in Mexico.
Review of the Draft Technovigilance Standard by COFEPRIS in Mexico.
US FDA Publication on Integrating Artificial Intelligence into Healthcare Product Copy
On March 2024, the FDA released its latest publication titled “Collaborative Efforts: Harnessing Artificial Intelligence in Medical Products,” shedding light on the concerted actions undertaken by CBER, CDER, CDRH, and OCP in navigating the landscape of AI integration within the medical product realm. This comprehensive document delineates strategic focal points essential for advancing the application of AI throughout the entire lifecycle of medical products.
” FDA determines that Medical Device Registrations must be submitted electronically from October 2025″
In August 2024, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced that starting in October 2025, medical device manufacturers must use the eSTAR (Electronic Submission Template and Resource) model for submitting new registration applications.