How does the FDA determine which performance testing is necessary for a particular device?

The US Food and Drug Administration (FDA) cleared the disc via the 510(k) pathway, which does not require clinical testing data. Instead, clearance is based on ... 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 ... It is important to seek feedback from FDA at a time when it will be of most value. o Initiating a pre-submission meeting early might mean that you still have ... Jan 10, 2013 ... Because many predicates have never been assessed for safety and effectiveness, an FDA finding of substantial equivalence does not mean that a ... Nov 29, 2023 ... With this unprecedented FDA clearance, Vivos redefines what it means to have a truly non-invasive treatment for all levels of OSA severity. 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 ... Oct 21, 2021 ... The Premarket Notification, or 510(k) submission, is the mechanism through which the majority of medical devices obtain US marketing clearance. Mar 21, 2022 ... Developing a new medical device? Here's how much time and cash it could take to get FDA 510(k) clearance or De Novo classification. Dec 30, 2024 ... SIMEOX 200 is predominantly aimed to help patients with chronic lung diseases associated with mucus hypersecretion and mucus retention, such as ... Mar 22, 2025 ... This determination means ... Ben Sexson, Monogram Chief Executive Officer, commented, “This FDA 510(k) clearance is a defining moment for Monogram ...