What is a 510(k)?
The term 510(k) originates from section 510(k) of the Federal Food, Drug, and Cosmetic Act. Also known as a premarket notification, a 510(k) submission allows the US Food and Drug Administration (FDA) to determine whether a device is substantially equivalent to a device already legally marketed in the US. Medical device manufacturers are required to submit a 510(k) if they intend to introduce a device into commercial distribution in the US for the first time or if they reintroduce a device that is changed or modified to the extent that its safety or effectiveness could be affected. Such a change may relate to the design, material, chemical composition, energy source, manufacturing process or intended use.
TÜV SÜD America has been involved in the FDA 510(k) third-party review program since its inception in 1996. Today, TÜV SÜD America offers third-party submission services for over 600 devices. For a list of devices TÜV SÜD America is eligible to review, visit the FDA website.
Manufacturers can also obtain FDA guidance on compiling their 510(k) through FDA Publications (FDA 95-4158 and FDA 89-4203), FDA’s website www.fda.gov and DSMA’s Facts-On-Demand service at 800 899 0381.