What resources are available to foreign manufacturers to help them navigate the FDA regulatory process?

Technically, the FDA does not “approve” medical devices or IVDs for sale under the FDA 510(k) premarket notification process. The FDA gives “clearance” for them ... Jan 30, 2023 ... ... dose concerns mean CT is not optimal. Adaptix's central mission is to transform radiology by offering affordable low-dose 3D imaging at the ... Apr 2, 2024 ... "Olympus is your trusted stone management partner and now is positioned to provide access to a broad range of high-quality ureteroscopes, ... 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, ... Feb 8, 2024 ... For comparison, the FDA mean review times were 150 days for 510(k)s ... And the 510(k) clearance pathway is generally easier and faster. Jan 10, 2023 ... Main Outcomes and Measures Class I or class II recall of a 510(k) medical device between its FDA regulatory clearance date and December 31, 2020 ... 8 days ago ... Laser endoscopy ophthalmic system receives FDA 510(k) clearance · Study: Home OCT impacts physician decision making · FDA does ... The mean IOP ... Sep 13, 2024 ... ... FDA clearance for counting coughs. What Does "510(k) Clearance" Mean? When a medical device receives 510(k) clearance from the U.S. Food and ... 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) ... May 6, 2021 ... What is the risk of recall and high-risk recall for devices undergoing US Food and Drug Administration (FDA) 510(k) clearance compared with ...