Medex International Medical Device Consulting can provide professional 510k certification services.
In order to market a medical device in the U.S., a manufacturer must go through one of two evaluation processes: Premarket Notification [510(k)] (if not pardoned by 510(k)), or Premarket Approval (PMA). Most medical devices that are commercially distributed in the United States are approved by way of a premarket notification [510(k)]. In some cases, neither a 510(k) nor a PMA is required for devices that were legally marketed prior to May 28, 1976.
The 510(k) document is a pre-market application document filed with the FDA to demonstrate that the device sought to be marketed is as safe and effective as a legally marketed device not subject to Premarket Approval (PMA), i.e., it is a substantially equivalent device ( substantially equivalent). The applicant must compare the device under application with one or more similar devices currently on the U.S. market and conclude that it is substantially equivalent. A legally marketed device is a device that was legally marketed before May 28, 1976 (pre-marketed device), or a device that was classified in Class II or I from a Class III device, or a device that was found to be equivalent to such a device through the 510(k) process, or a device that was established through an automated evaluation of the definition of a Class III device. Equivalent devices are referred to as "predicate device(s)". The applicant must submit descriptive data and, if necessary, performance data to show that the device is the equivalent of a predicate device. Again, the 510(k) data is data showing similarity, i.e., the degree to which the new device is equivalent to the predicate device.