How does the FDA communicate information about recalls or safety alerts related to predicate devices?

Jan 21, 2022 ... The BioFire COVID-19 Test 2 is an in vitro diagnostic test used in conjunction with the BioFire FilmArray instrument to analyze nasopharyngeal swab, or NPS, ... What is an Ebook? Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared ... 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. Jan 16, 2001 ... Because FDA may be unaware that ownership of a 510(k) has changed, the notification by Internet site would serve as an additional means of ... Sep 29, 2023 ... Many Software as a Medical Device and AI developers are looking to the US for a cheaper and speedier regulatory approval via an FDA 510(k) ... Oct 6, 2020 ... Although FDA's 510(k) program is the most ... clearance, meaning that manufacturers can market their device without clearance from the FDA. Feb 11, 2025 ... That's actually why screening is so important—it doesn't have symptoms until it's advanced. For example, bone pain would mean the cancer has ... 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, ... Oct 1, 2024 ... ... (FDA) for its PlaqueIQ™ imaging analysis software to help physicians diagnose cardiovascular disease (CVD). PlaqueIQ is the first FDA-cleared ... The FDA's 510(k) submission process is, in a nutshell, a clearance process which every company wanting to bring a medium-risk medical device to the American ...