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Quick answer: Most mobile health apps do not need FDA authorization. Fitness tracking, meditation, nutrition logging, and other general wellness tools are typically not regulated, as long as they avoid disease-specific diagnostic or treatment claims. Apps are more likely to be regulated as medical devices when they have a medical intended use, for example diagnosing disease, treating or preventing medical conditions, analyzing medical images or signals (ECG, EEG, imaging), or

Software as a Medical Device (SaMD) is software intended for one or more medical purposes that performs those purposes without being part of a hardware medical device (IMDRF definition used by FDA). SaMD typically runs on general-purpose platforms like phones, tablets, PCs, or cloud servers. If your software’s intended use is to diagnose, treat, mitigate, cure, prevent disease, or drive clinical decision-making, it may be regulated as a medical device unless it fits an exclus

The FDA just mentioned AI in a warning letter. Before you panic, read what it actually said. A lot of people in regulated industries are skeptical of AI. Honestly, they are not wrong. There is already too much noise. Too many tools overpromising and underdelivering. So when FDA mentions AI in a warning letter, people pay attention. They should. But for the right reason. FDA did not reject AI. FDA rejected blind reliance. In its April 2026 warning letter to Purolea Cosmetics L

Quick answer: Your FDA medical device classification (Class I, II, or III) is based on risk and the controls needed to assure safety and effectiveness. You can usually find it by searching FDA’s Product Classification resources, then confirming the regulation number (21 CFR 862–892) and product code (3-letter code) that match your intended use and technology. FDA has classified over 1,700 generic device types across 16 medical specialty panels. Classification drives your like

FDA establishment registration tells FDA where medical devices are made or processed (for example manufacturing, sterilization, relabeling, repacking) and carries an annual establishment registration fee of $11,423 for FY2026. Device listing tells FDA which devices are associated with that establishment, and when applicable it includes the relevant premarket reference such as a 510(k), De Novo, PMA, or an exemption status. Annual registration must be submitted each year betwe

FDA can help you sell beyond America A lot of international manufacturers still ask the wrong question: “Is FDA clearance worth it if the U.S. is not our main market?” That is too narrow. Yes, the U.S. matters. It is still the world’s largest medical device market, with about 40% of global share . But for some manufacturers, the bigger value of FDA is not just access to America. It is what FDA helps you do outside America: sell in markets with stringent regulatory requiremn