How is the FDA working to provide clarity and guidance in the regulation of digital health?

FDA clearance through the 510(k) process means the agency is in agreement with the manufacturer that a medical device is similar to a previously approved ... Sep 6, 2023 ... A Premarket Notification [510(k)], when the device is low to moderate risk and there is a legally marketed predicate device. Regardless of the ... FDA Cleared: When used correctly, this term refers to FDA allowing a device to market through the 510(k) process based on substantial equivalence to a legally ... Jan 3, 2024 ... May is an incredibly variable month for FDA decision-making and I don't honestly know why. Variability means that there's a lack of consistency, ... Leading letter “K” indicates 510(k) clearance, or Premarket Notification. This is an .exact field. It has been indexed both as its exact string content, and ... Jan 24, 2023 ... What does this all mean for you? It means we did the work to ... What that means: A 510(k) filing contains detailed technical, safety ... Feb 14, 2025 ... The goal of the 510(k) submission is to demonstrate that the device is "substantially equivalent" to a device that has already been cleared by ... Mar 22, 2025 ... This determination means ... Ben Sexson, Monogram Chief Executive Officer, commented, “This FDA 510(k) clearance is a defining moment for Monogram ... Feb 8, 2024 ... For comparison, the FDA mean review times were 150 days for 510(k)s ... And the 510(k) clearance pathway is generally easier and faster. Sep 13, 2024 ... ... FDA clearance for counting coughs. What Does "510(k) Clearance" Mean? When a medical device receives 510(k) clearance from the U.S. Food and ...