Where can manufacturers find additional information and resources about the FDA 510(k) process?

Dec 22, 2021 ... The FDA clearance is based on data from multiple studies of the ... mean tear film breakup time and meibomian gland secretion score ... 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, ... FDA 510(k) Medical Device Clearance. The 510(k) pathway is based on ... A claim of substantial equivalence does not mean the device(s) must be identical. To receive FDA approval on a new device intended for human use, a premarket submission called a 510k must be made to the FDA. This must demonstrate that the ... Sep 19, 2022 ... The 510(k) approval process is an FDA requirement for medium-risk medical devices such as self-fitting hearing aids. Jul 29, 2024 ... The FDA's action means that SPIRA-A Integrated is now indicated for use at one or more levels, from L1-S1 as an adjunct to fusion in skeletally ... 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, ... The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of ... 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 22, 2025 ... This determination means ... Ben Sexson, Monogram Chief Executive Officer, commented, “This FDA 510(k) clearance is a defining moment for Monogram ...