Product

FDA Related Services

June 16, 2010

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’s Role

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.

Benefits of using TÜV SÜD America

• In addition to providing 510(k) reviews for US market access, TÜV SÜD America can provide market access to Europe, Canada and Japan offering manufacturers a single-source solution to their regulatory needs.
• TÜV SÜD America is approved to review all eligible Class I and Class II devices. Our authorisation to review all eligible devices is reflective of the strength of our staff and our dedication to the industry. Currently, TÜV SÜD accounts for over half of the third-party 510(k) submissions.
• Prompt service is the hallmark of our reputation. For our 510(k) services this means that if the 510(k) submission requires additional information, TÜV America will continue the review process (if possible) while waiting to receive any missing information.
• As part of our commitment to facilitating open communication, our staff will stay in contact with manufacturers throughout the review process. This greatly accelerates the review process because we are able to address and correct any issues or omissions as they arise.

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.