==Pre-Market Notification==
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers.
A 510(k) is required when:
* Introducing a device into commercial distribution (marketing) for the first time.
* Proposed different intended use for a device already in commercial distribution.
* Change or modification of a legally marketed device.
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]
Some of the companies active in the field of ureteral stents have been represented in the table below.
