The FDA 510(k) submission is a crucial step for manufacturers seeking to introduce or modify medical devices in the U.S. market. This process ensures that a device is substantially equivalent to one already legally marketed in the U.S., thereby demonstrating its safety and effectiveness. While it is not as https://thedirectoryblog.com/listings12979330/navigating-the-fda-510-k-submission-process-for-medical-devices