What are the recent changes and updates to the FDA's guidance documents on 510(k) submissions?

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, ... Dec 30, 2024 ... SIMEOX 200 is predominantly aimed to help patients with chronic lung diseases associated with mucus hypersecretion and mucus retention, such as ... Following is a breakdown of 510(k) exempt and Good Manufacturing Practice ... FDA is taking this action in order to meet requirements of FDAMA and the ... Oct 24, 2023 ... 510(k) clearance is the FDA's primary regulatory process. It is ... This means that the current state of the art is no longer guaranteed. Jan 30, 2025 ... In addition to the clearance, AI Optics is ... A total of 196 patients (48.5% women; mean age, 61 years) were identified who had been referred for ... 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 ... Jan 24, 2023 ... What does this all mean for you? It means we did the work to ... What that means: A 510(k) filing contains detailed technical, safety ... Leading letter “K” indicates 510(k) clearance, or Premarket Notification. This is an .exact field. It has been indexed both as its exact string content, and ... Premarket Notification vs Premarket Approval. Phillips stressed that the premarket notification, or 510(k), process is a classification process, whereas PMA is ... Mar 17, 2025 ... This determination means ... Ben Sexson, Monogram Chief Executive Officer, commented, "This FDA 510(k) clearance is a defining moment for Monogram ...