07 May, 2024 Exploring Regulatory Hurdles: How to Navigate FDA Approval for AI-Enabled Medical Devices By Austin Kim This article provides an overview of the FDA's approval process for AI-enabled Software-as-a Medical-Device (SaMD). Under the current...
31 Jan, 2024 FDA/CDRH's Take on the Growing Importance of Transparency in AI/ML-Enabled Medical Devices By Austin Kim Beyond traditional regulatory concerns, the U.S. Food and Drug Administration (FDA) is currently navigating the challenges of usability,...
16 Aug, 2023 FDA Issues New Guidance on Informed Consent By David Rosen FDA has stated the guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying...
08 Aug, 2023 FDA Issues Guidance on Cosmetic Registration and Listing By David Rosen Cosmetic companies are required to submit facility registration and product listing information on cosmetic products that they...