510(k) Applications
TUV America Inc. is authorized by the FDA under the Accredited Persons program to submit 510(k) applications on behalf of medical device manufacturers for all eligible Class I & II devices. TUV America has been involved in the FDA 510(k) third-party review program since its inception in 1996. Today, TUV offers third-party submission services for over 600 devices.

Also known as a premarket notification, a 510(k) submission allows the U.S. Food and Drug Administration (FDA) to determine whether a device is substantially equivalent to a device already legally marketed in the United States. 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.

Third-Party FDA Inspections
TUV America is also authorized to provide Third-Party FDA Inspections. Under the FDA's Inspection by Accredited Persons program, TUV America Inc. is accredited as an "Accredited Person" to conduct inspections of eligible class II and III medical device manufacturers.

This program provides manufacturers an alternative to the traditional FDA inspection. By utilizing an Accredited Person, manufacturers can decrease disruptions by combining multiple country audits, saving time, resources, and money.

Benefits of using TUV America
Currently, TUV accounts for over half of the third-party 510(k) submissions, proving our strength and dedication to the industry. In addition to providing 510(k) reviews for US market access, TUV can provide market access to Europe, Canada and Japan, offering a single-source solution to your regulatory needs. Plus, we pride ourselves on fostering close relationships with our customers. This translates to prompt service, open communication and an accelerated review process.

Contact us today for more information on TUV America's FDA-related services.