FDA Issues Final Guidance on Medical Devices with Indications Associated with Weight Loss
The FDA has issued final guidance on medical devices with indications associated with weight loss, outlining regulatory expectations for clinical studies, non-clinical testing, and benefit-risk evaluation.
New FDA Draft Guidance Sets Bar for Cuffless Blood Pressure Devices – Clinical Performance Now in Focus
The FDA has released a draft guidance outlining new clinical performance requirements for cuffless non-invasive blood pressure devices. Manufacturers using wearable sensors or AI must now meet specific testing standards, including ISO 81060-2. Learn how these updates affect premarket submissions and regulatory strategies.
FDA Draft Guidance Aligns QMS Requirements with ISO 13485: What It Means for Medical Device Manufacturers
The FDA has released a draft guidance aligning U.S. Quality Management System (QMS) requirements with ISO 13485:2016. This change simplifies compliance for medical device and IVD manufacturers and distributors, ensuring global harmonization and streamlined FDA premarket submissions effective February 2026.