What types of communication should a manufacturer expect from the FDA during a 510(k) review?

Jun 5, 2024 ... A legally marketed predicate means the device has previously gone through a 510(k) clearance process and obtained FDA clearance or was on the ... Apr 17, 2025 ... Leos is supported by emerging data from a randomized controlled clinical trial, further validating its safety and efficacy. Mar 22, 2025 ... This determination means ... Ben Sexson, Monogram Chief Executive Officer, commented, “This FDA 510(k) clearance is a defining moment for Monogram ... Nov 13, 2024 ... It includes the latest features used in molecular imaging and simplifies workflows significantly. This is a new milestone in NM Processing and ... Jun 14, 2021 ... ... 510(k) process is focused on equivalence, not safety.'"10. The Court was critical of the amount of time and resources the FDA spends on 510(k) ... The 510(k) pathway allows the clearance of a new medical device if the manufacturer shows that the device is substantially equivalent to one or more legally ... Nov 22, 2024 ... The US Food and Drug Administration (FDA) 510(k) clearance of remote scanning and remote protocol adjustment features on Philips Radiology Operations Command ... Jan 7, 2025 ... This new, 25-gauge 180-mm Smart Tip will allow for the treatment of deeper nerves, such as the medial branch nerve and is specifically designed so that it can ... Jan 29, 2025 ... 2 Molarity assay is an in-vitro test measuring lipoprotein (a) in a person's bloodstream (serum and plasma), and will be broadly available on ... Apr 17, 2025 ... This 510(k) clearance is a testament to years of effort, and we are excited to bring this groundbreaking technology to physicians and their ...