How does the FDA regulate different types of catheters and implants used in urology and gynecology?

Premarket Notification vs Premarket Approval. Phillips stressed that the premarket notification, or 510(k), process is a classification process, whereas PMA is ... 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. 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 ... Apr 16, 2017 ... FDA's analysis of whether to exempt a type of device from the 510(k) requirements is specific to the devices within the generic category in ... Jan 10, 2013 ... Because many predicates have never been assessed for safety and effectiveness, an FDA finding of substantial equivalence does not mean that a ... Aug 22, 2022 ... The step means that Nerve Tape's development partner, Atlanta ... Nerve Tape is the company's first FDA-cleared medical device and ... Feb 14, 2025 ... The goal of the 510(k) submission is to demonstrate that the device is "substantially equivalent" to a device that has already been cleared by ... TPRG specializes in the review of 510(k) submissions, providing you with efficient FDA clearance. The Third Party Review Group is the expert in 510K TPR ... 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, ... Apr 17, 2025 ... Leos is supported by emerging data from a randomized controlled clinical trial, further validating its safety and efficacy.