@kj

LESS FDA regulation announced for certain digital health products. 🤔 The FDA has recently eased its regulatory oversight for certain low-risk AI-enabled products and consumer wearables by updating two key guidance documents. This move aims to promote innovation and accelerate the time-to-market for these technologies. 👇 1. General wellness products (wearables) are defined as non-invasive, over-the-counter wearables that measure physiological metrics like blood pressure, oxygen saturation, and glucose. If these products are intended solely for general wellness and don’t make explicit diagnostic or treatment claims, they can bypass the agency’s premarket review process.  2. Clinical Decision Support (CDS) software, including generative AI features, may be subject to FDA enforcement discretion if a healthcare provider can independently review the logic and data inputs (transparency is crucial). Previously, products offering a single recommendation were more likely to be classified as regulated medical devices. Shameless self plug, my project OrthoIQ https://orthoiq.vercel.app built from day one with MD oversight of AI responses. 👌

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