How can manufacturers engage with the FDA early in the device development process to discuss regulatory strategy?

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 ... Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, and the ... 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 ... Jan 12, 2024 ... The COVID-19 public health emergency (PHE) declaration expired on May 11, 2023, which means termination of medical device Emergency Use ... Deliver more personalised digital-first care and research with our enterprise platform which now has FDA 510 (K) Class II clearance for any physician-specified ... Jan 17, 2023 ... Henry further said it's important to keep in mind that the definition of “recall” is broad and doesn't necessarily mean a product was so ... The goal of a FDA 510k submission is to demonstrate that the device being brought to market is at least as safe and effective to another legally marketed ... 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 ... Sep 19, 2022 ... The 510(k) approval process is an FDA requirement for medium-risk medical devices such as self-fitting hearing aids. Nov 30, 2020 ... The 510(k) regulatory clearance pathway is used to demonstrate to the FDA ... Notably, “substantially equivalent” does not mean identical!