Can a manufacturer use their own previously cleared device as a predicate?

Apr 2, 2024 ... Designed for symptomatic individuals within six days of symptom onset, the QuickVue COVID-19 test is cleared for use in individuals aged 14 or ... Mar 7, 2022 ... Section 510(k) is a section of the Food, Drug and Cosmetic Act (FD&C Act) that requires device manufacturers to provide the Food and Drug ... The goal of a FDA 510k submission is to demonstrate that the device being brought to market is at least as safe and effective to another legally marketed ... Companies can submit a 510(k) — also known as a premarket notification (PMN) — to the FDA to show that the device is substantially equivalent. This process is ... 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 ... Aug 12, 2021 ... When a medical device is cleared, this means it has undergone a 510(k) submission, which the FDA has reviewed and provided clearance. For Class ... 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. Feb 7, 2024 ... One crucial milestone for many health apps is obtaining 510(k) clearance from the US Food and Drug Administration (FDA). But what exactly does ... 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 ... Oct 1, 2024 ... ... (FDA) for its PlaqueIQ™ imaging analysis software to help physicians diagnose cardiovascular disease (CVD). PlaqueIQ is the first FDA-cleared ...