What role do FDA guidance documents play in understanding the requirements for demonstrating substantial equivalence?

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of ... Mar 17, 2025 ... What does the FDA 510(k) clearance mean for Monogram's mBôs TKA System (MGRM)?. The clearance allows Monogram to legally market and sell ... FDA has a clear definition of the 510(k) pathway which allows manufacturers ... FDA's Premarket Approval (PMA) pathway. The European Union CE marking ... Nov 30, 2020 ... The 510(k) regulatory clearance pathway is used to demonstrate to the FDA ... Notably, “substantially equivalent” does not mean identical! Jul 3, 2024 ... What exactly does this mean? I have heard this tossed around for some time and want to learn more about the specifics of a FDA 510(k) ... Oct 21, 2021 ... The Premarket Notification, or 510(k) submission, is the mechanism through which the majority of medical devices obtain US marketing clearance. 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 ... Jul 21, 2016 ... The INTRACEPT System is the first specific therapy to relieve chronic low back pain (CLBP) of at least six months duration that has not responded to at least ... Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, and the ... 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.