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FDA requires medical device labeling to include manufacturer information, intended use, adequate directions, warnings, UDI (where applicable), and device-specific requirements. Labeling encompasses all written materials including labels, packaging, instructions for use, and promotional materials. Compliance requires both content accuracy and quality system controls under 21 CFR 820.120. This guide covers all FDA labeling requirements, common violations, and compliance strateg

Whether you need FDA approval, FDA clearance, or no regulatory submission at all depends on your device's risk classification and intended use. FDA approval (PMA) is required for high-risk Class III devices. FDA clearance (510(k)) is needed for most Class II devices and some Class I devices. However, most Class I devices and many Class II devices are exempt from premarket submissions but still require FDA registration and listing. This guide provides a complete decision frame

CMS New Technology Add-on Payment (NTAP) is the fastest path to Medicare reimbursement for by providing additional Medicare payments...

The EU AI Act is a risk-based regulation requiring AI medical devices to undergo dual compliance, single integrated CE: NB assesses AIA +...

EU AI Act requires separate AI system certification alongside medical device approval, with 36-month implementation timeline. FDA's PCCP...

IMDRF is the global forum harmonizing medical device regulations across major markets (FDA, MHRA, Health Canada, EU). On Jan, 2025, IMDRF...